Quality Of Medicinal Products Research Articles

Metrological Requirements to Measuring Equipment (Review)

Introduction . Qualification of equipment is one of the crucial aspects of quality assurance of medicinal products that ensures consistency of metrological characteristics. Elaboration of local guidances on qualification of measuring instruments, and harmonisation of the qualification procedure with the requirements of the European and American regulations will help to improve the quality of medicinal products manufactured in Russia and to facilitate their competitiveness on the global pharmaceutical market. Text . The aim of this review is to analyse the Russian regulatory framework regarding the consistency of metrological characteristics of measuring equipment used in the pharmaceutical industry. The article contains information on the special aspects of confirmation of compliance of equipment to the metrological requirements stated in various regulatory documents in force in the Russian Federation. Conclusion . The article demonstrates the ambiguity of interpretation of the Russian regulatory framework and European quality recommendations regarding metrological requirements to measuring equipment. Elaboration of the local guidance harmonizing metrological requirements to equipment will help to focus on the result and the quality of medicinal products, and to eliminate the ambiguity of interpretation of the Russian regulatory framework.

Methodological Approaches to Determination of Depressor Substances in Medicinal Products

In order to harmonise national and foreign requirements for quality control of medicinal products, a second variant of the test method, which complies with the requirements of the European Pharmacopoeia, was included into the general monograph OFS.1.2.4.0008.18 “Test for depressor substances”. The aim of the study was to compare the two variants of the in vivo test method that uses cats for determination of depressor substances in medicinal products and to develop recommendations for the use of these two variants of the test method. The comparative analysis of the two ways of determining impurities that lower blood pressure revealed different approaches to performing the test and to testing an animal's sensitivity to the reference solution (histamine dihydrochloride). It was demonstrated that different concentrations, volumes, and doses of medicinal products are used to assess the results of testing performed by variants 1 and 2 of the test method according to the pharmacopoeial requirements. Based on the established differences in the methodological approach to determination of depressor substances in medicinal products, the authors developed recommendations for each of the test variants. The inclusion of two variants of the test method in the general monograph provides an opportunity to evaluate the quality of medicinal products under the most appropriate conditions and, consequently, to improve the validity of test results.

Toxicity of heavy liquids

Acute toxicity of perfluorocarbon liquids (PFCL) is arelevant problem in retinal surgery due to impurities in the medicinal product. This article gives an overview of the current problems, possible explanations, interactions with other medicinal products and approaches to improved patient safety. Toxicity is caused by impurities in the raw material but can also be caused by interactions with other medicinal products or drugs. The current test procedures do not ideally represent the ophthalmological application but there are promising activities to set the course for the future. The use of PFCL in retinal surgery is generally considered safe. Users should pay attention to the quality of medicinal products.

Development of a New Dosage Form of Herbal Medicinal Products

The «cut-and-pressed granules» dosage form was developed to improve the technological properties of cut and powdered herbal substances in order to compensate for their insufficient flowability, as well as to facilitate dosing, reduce the contamination of the production equipment with dust and contamination of water extracts with dietary fibers. Based on the results of the information research the authors chose an optimal technology for the production of cut-and-pressed granules from some types of herbal substances (Rose hips, Bearberry leaf, Thyme herb, Melissa herb, Oregano herb, Motherwort grass, Matricaria flower). The authors standardised the new dosage form, developed the list of test parameters, test methods, and regulatory requirements for the quality of medicinal products based on the technological features of the new dosage form. Cut-and-pressed granules should not be produced from herbal substances that contain essential oils and coumarins, as it was demonstrated that the content of these compounds may decrease in the process of wet granulation. To determine whether it is possible to produce cut-and-pressed granules from a particular type of raw material, it is necessary to conduct comparative experimental studies confirming that the quality of aqueous extracts obtained from powdered herbal substances in sachets is comparable to that of tinctures or decoctions obtained from cut-and-pressed granules packed in sachets. The materials of the study were used to draft the general chapter OFS.1.4.1.0022.15 «Cut-and-pressed granules». This dosage form is not described in any foreign pharmacopoeias.

Geographic-based metabolomic variation and toxicity analysis of Sutherlandia frutescens L. R.Br. – An emerging medicinal crop in South Africa

Sutherlandia frutescens (syn. Lessertia frutescens), an indigenous southern African species, is important for the local and global phytomedicine's industry. As farming of medicinal plants in South Africa is not extensive, wild populations are also used as a source of material to bulk available cultivated yields prior to industrial processing. This may cause inconsistency in the quality of medicinal products derived from this species, inducing discrepancies in the plant’s therapeutic profile. The current study aimed to elucidate the phytochemical variations among S. frutescens plants growing in different geographical localities, especially in areas which have not been studied before. One set of extracts were generated using a 50% acetonitrile and formic acid solution (0.1%) (v/v). By using a targeted metabolomics approach, two major phytochemical groups, sutherlandins and sutherlandiosides were used to display metabolite-based clusters after LC–MS/MS analysis. Plants from different geographical locations grouped into separate chemical lineages. Another set of ethanol and aqueous extracts of pooled leaf materials were screened for their toxicity effect on the hatching rate of zebrafish embryos and mortality of larvae at different concentrations, ranging from 5 to 300 μg ml−1. We also calculated the LC50 values using a zebrafish microplate bioassay and this value was 297.57 μg ml−1 for the water extract. The aqueous extracts were relatively less toxic compared to ethanol extracts (LC50 value of 40.54 μg ml−1). Both the hatching rate and mortality were negatively affected by increasing extract dosages. The highest concentrations, between 200 to 300 μg ml−1, caused acute lethal effects for both extract types. This study adds additional evidence of the cytotoxicity reported by others in this species and will further aid in the domestication of S. frutescens.

International Logistics Criteria on Medicinal Products for Human Use

Medicinal products for human use relates to international logistics of pharmaceutical raw materials to the world people’s health and life, therefore international logistics provider plays an important part in order to ensure the stability of the quality of medicinal products. This study investigates international logistics provider to establish pharmaceutical industry outsourcing client satisfaction under international logistics criteria to confront with pharmaceutical good distribution practice (GDP) and good manufacturing practice (GMP) on medicinal products for human use. In the first phase, the international drug logistics criteria are referred from domestic and international GDP and GMP procedures and past literature review basis on outsourcing client logistics satisfaction. The second stage is the establishment of a standard questionnaire following the Delphi method. According to Delphi procedures, this study establishes logistics service criteria questionnaire items base on ten experts’ opinions and suggestions. After collecting the Delphi questionnaire, we realize the international logistics service provider lack the concept of the GDP logistics criteria, resulting in differences on the demand for logistics service. The logistics industry should take the initiative to pay attention to the GDP criteria that demand-side and supply-side consistency awareness in order to achieve the best logistics criteria. Through expert experience and specification to build a set of international logistics criteria for the pharmaceutical industry in order to provide international logistics provider to shorten or reduce the barriers to entering current international medicinal products for human use market to create high profit competitive environment.

ELIMINATION OF FALSE RESULTS OF MEDICINES MICROBIOLOGICAL TESTING

The validity of medicines microbial quality testing relies on the adequacy of the test procedure employed. The aim of the study was to analyse factors triggering false results during microbial quality testing of non-sterile medicinal products, as well as to find ways of their elimination. Materials and methods: the study was focused on non-sterile medicinal products tested for microbial quality: N-methylglucamine, L-Malic acid, Xeroform, Fingolimod hydrochloride, Succinic acid, Streptocide, Aripiprazole, Doxazosin, Clopidogrel, Moxonidine, Tilorone, Mycophenolic acid, Folic acid, Gabapentin, Dutasteride, Imatinib, Temozolomide. The study involved the use of the following test strains: Bacillus subtilis, Bacillus cereus, Candida albicans, Escherichia coli, Aspergillus brasiliensis, as well as of reagents and growth media. The methods used were determination of antimicrobial activity under conditions of microbial quality testing, and modified in-depth testing of microbial quality of medicinal products according to the requirements of the State Pharmacopoeia of the Russian Federation, 13th edition. Results: the analysis of literature sources helped reveal the main factors causing false results of microbiological testing and determine ways of their elimination. The article sets forth the results of experimental comparison of two ways of sample preparation for solid formulations: the standard one described in the State Pharmacopoeia of the Russian Federation, 13th edition, and the one involving the use of a laboratory shaker. The article provides experimental data on specific aspects of elimination of antimicrobial activity against B. subtilis and B. cereus and the use of specific inactivators for particular medicinal products. Conclusions: a set of measures aimed at prevention of false-positive and false-negative testing results should include: sterility control of the growth media and reagents used, monitoring of facilities; control of growth promotion properties and selectivity of the growth media; selection of adequate incubation conditions and inoculation procedure with due regard to the dosage form; justification of the amount of sample, diluents and dilution factor used; consideration of the antimicrobial activity of a medicinal product.

Quality risk management during pharmaceutical ‘good distribution practices’ – A plausible solution

Quality of medicinal product is an important facet throughout lifecycle owing to its importance as acceptance criteria at customer’s end. Drugs regulatory agencies have issued guidelines for quality risk evaluation, mitigation and review management. Quality risk management has become an integral part of quality management system at manufacturing plants. Procedures for deviation control, change control, investigations of market complaints and batch failures are dealt with the principle of quality risk management at the manufacturing facility. The exploratory study shows a dearth of research on quality risk management during supply chain operation, however, a few study has been carried out by keeping financial risk into account. This study addresses the gap in literature on quality risk management during supply chain operations. There are cases of unresolved customer complaints and batch failures originated due to inadequacies during distribution of pharmaceutical products. In absence of established quality risk management system during product shipment, there is no effective preventive plan related to risk factors. A corollary of manufacturing quality risk management has been drawn to the distribution of pharmaceutical products through this study. The quality risk management during pharmaceutical distribution may be useful to avoid market complaints, drug recalls, and regulatory actions. This study produces one unique model solution for industry professionals and policymakers opening a scope to reduce the product rejection thereby paving the way for substantial business growth.

Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use.

The aim of this study was to identify trends in deficiencies raised during the EU evaluation of the quality part of dossiers for marketing authorisation applications of biosimilar medicinal products. All adopted day 120 list of questions on the quality module of 22 marketing authorisation applications for biosimilars submitted to the European Medicines Agency and concluded by the end of October 2015 was analysed. Frequencies of common deficiencies identified were calculated and summarised descriptions included. Frequencies and trends on quality deficiencies were recorded and presented for 22 biosimilar applications. Thirty-two 'major objections' for 9 products were identified from 14 marketing authorisation applications with 15 raised for drug substance and 17 for drug product. In addition, 547 'other concerns' for drug substance and 495 for drug product were also adopted. The frequencies and trends of the identified deficiencies together with their impact were discussed from a regulatory perspective and how these impact key manufacturing processes and key materials used in the production of biosimilars. This study provides an insight to the regulatory challenges prospective companies need to consider when developing biosimilars; it also helps elucidate common pitfalls in the development and production of biosimilars and in the submission of dossiers for their marketing authorisations. The results are expected to be of interest to pharmaceutical companies but also to regulators to obtain consistent information on medicinal products based on transparent rules safeguarding the necessary pharmaceutical quality of medicinal products.

Personnel hygiene in pharmaceuticals: Its importance and requirements for personnel involved in the manufacturing of quality medicines

Good personal hygiene is required in pharmaceutical industries to safeguard the product and avoid any type of contamination that effects quality of medicinal product. Individual persons are responsible for quality of a medicinal product and hence collectively can be termed as “personnel”. Even though controls are in place to manage equipment, incoming raw materials or packing materials, human beings are one of the main source of contamination. It is not enough to have a high tech state of the art pharmaceutical manufacturing facility and Quality control unit to release the raw materials, it is also very much essential to have well trained personnel to operate the equipment, to manufacture the quality product and handle the pharmaceutical product at every stage in manufacturing a dosage form. Therefore, all the personnel employed by the pharmaceutical sector should be well trained and educated on the importance of personnel hygiene. In this article, the authors have tried to outline importance of personnel hygiene and opined that there is a need to stress more on this subject especially at undergraduate levels of pharmacy curriculum. If this is included at undergraduate level, it will be easy to inculcate the best practices as per Good Manufacturing Practices (GMP) for the freshers entering the pharmaceutical manufacturing sector.

A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error.

The primary purpose of method validation is to demonstrate that the method is fit for its intended use. Traditionally, an analytical method is deemed valid if its performance characteristics such as accuracy and precision are shown to meet prespecified acceptance criteria. However, these acceptance criteria are not directly related to the method's intended purpose, which is usually a gurantee that a high percentage of the test results of future samples will be close to their true values. Alternate "fit for purpose" acceptance criteria based on the concept of total error have been increasingly used. Such criteria allow for assessing method validity, taking into account the relationship between accuracy and precision. Although several statistical test methods have been proposed in literature to test the "fit for purpose" hypothesis, the majority of the methods are not designed to protect the risk of accepting unsuitable methods, thus having the potential to cause uncontrolled consumer's risk. In this paper, we propose a test method based on generalized pivotal quantity inference. Through simulation studies, the performance of the method is compared to five existing approaches. The results show that both the new method and the method based on β-content tolerance interval with a confidence level of 90%, hereafter referred to as the β-content (0.9) method, control Type I error and thus consumer's risk, while the other existing methods do not. It is further demonstrated that the generalized pivotal quantity method is less conservative than the β-content (0.9) method when the analytical methods are biased, whereas it is more conservative when the analytical methods are unbiased. Therefore, selection of either the generalized pivotal quantity or β-content (0.9) method for an analytical method validation depends on the accuracy of the analytical method. It is also shown that the generalized pivotal quantity method has better asymptotic properties than all of the current methods. Analytical methods are often used to ensure safety, efficacy, and quality of medicinal products. According to government regulations and regulatory guidelines, these methods need to be validated through well-designed studies to minimize the risk of accepting unsuitable methods. This article describes a novel statistical test for analytical method validation, which provides better protection for the risk of accepting unsuitable analytical methods.

Phenolic content distribution and antioxidant activities of <i>Terminalia sericea</i> Burch

Background: Terminalia sericea has been used traditionally for the treatment of diseases associated with oxidative stress. This study was aimed at determining the distribution of phenols in the leaves, stem bark and root bark of Terminalia sericea and their antioxidant activity.Materials and methods: Hot and cold water, methanol/acetone extracts were evaluated for their total phenolic content (TPC), flavone/flavonol content (FFC), flavonone/dihydroflavone content (FDFC), hydroxycinnamic acid derivative content (HCAC) and tannin content (TC). DPPH (2,2-diphenyl-1-picrylhydrazyl) free radicals and reducing power assays were used to assess the antioxidant activity.Results: The leaves had the highest average TPC (440) expressed in milligram Gallic Acid Equivalent (mgCAE) /gram of the extract. The leaves also had the highest average TC (7.14) expressed in milligram Quercetin Equivalent (mgQE) /gram of the extract. The stem had the highest average FDFC (19.23 mgQE/g) while the root had the highest average FFC (74.76 mgQE/g) and HCAC (214.57) expressed in milligram Caffeic Acid Equivalent mgCAE/ gram of the extract. The stem exhibited the highest average DPPH free radical scavenging (9.85 μg/mL) and reducing power (6.01 μg/mL) activities. Water was a better extracting solvent for TPC and FDFC while methanol/acetone was a better extracting solvent for FFC and HCAC. The correlation between TC and reducing power activity (r=0.668) at P < 0.05 suggests that tannins were responsible for the antioxidant activity.Conclusion: This study has shown that the distribution of phenolics differs in the organs of T. sericea, and could affect the quality of medicinal products sold.Key words: Phenolic contents; Terminalia sericea; Antioxidant activity; Distribution studies.

The Concept of Research of Pharmacists Professional Training in Ukraine

Despite an increased focus of the Ukrainian scientists (V. Lazoryshynets, O. Volosovets, I. Vitenko, Ya. Tsekhmister, V. Chernykh, and others) on the issue of professional training of pharmacists, today it still remains insufficiently studied, and taken European integration into account it requires significant attention. The concept of pharmacists professional training in Ukraine implies that pharmaceutical education, i.e. the structure, content, timeframes, and quality, should be brought to conformity with the state and international standards and with the demand of the country's healthcare system for high-quality pharmaceutical aid provided to population, for supply of good medicinal products in sufficient amounts, for the development of new technologies in production of medicinal products, for maintaining the nation's health. The system of continuous professional training of pharmacists in Ukraine comprises three successive stages, integrated between each other since every next stage is based on the previous and backs the new, higher level of pharmacists professional training, namely undergraduate training, postgraduate studies, continuous (lifelong) professional development. The ultimate goal of pharmacists professional training in Ukraine is to achieve objectives such as improving the quality of medicinal products and pharmaceutical aid; maintaining and strengthening the nation's health; promoting the quality of education, research and professional activities of higher educational and postgraduate institutions offering pharmaceutical education; competitiveness of pharmacists in the European and international labor markets.

An Insight into the Difficulties of Software Development Projects in the Pharmaceutical Industry

 Abstract—Software development projects in the pharmaceutical industry are highly regulated as software failures can have a direct impact on the quality of medicinal product and therefore patient safety. Regulation is imposed from a governmental level but is also employed in the form of comprehensive industry standards. The strive for regulatory compliancy is a direct cause for high overhead in software development projects, which leads to the procrastination of innovation. 14 interviews have been conducted with domain experts in a quest to understand and validate the difficulties of software development projects in the context of the pharmaceutical industry. The interviews focussed on the difficulties of software development projects in the pharmaceutical context and the lack of adoption of agile methods, as these have proven to reduce overhead of software development projects in other industries. The collected information is disclosed for the purpose of advancing the research area which is characterised to be minimally researched.

The legal framework governing the quality of (traditional) herbal medicinal products in the European Union

In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such a marketing authorisation are laid down in regulations, directives and scientific guidelines. This paper gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation. Pharmaceutical quality of medicinal product is the basis for ensuring safe and effective medicines. The basic principles governing the assurance of the quality of medicinal products in the European Union are primarily defined in the amended Directive 2001/83/EC and Directive 2003/63/EC. Quality requirements of herbal medicinal products are also laid down in scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in regulations and directives. Detailed quality requirements for herbal medicinal products on the European market are contained in European Union (EU) pharmaceutical legislation. They include a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community. The European regulatory framework encompasses specific requirements for herbal medicinal products. These requirements are independent from the legal status. Thus, the same quality standards equally apply to herbal products based on clinical evidence and traditional herbal medicinal products. The basic principle is that the quality of herbal medicinal products is intrinsically associated with the quality standard of the herbal substances and/or herbal preparations. Furthermore, the herbal substance or herbal preparation in its entirety is regarded as the active substance. Consequently, a mere determination of the content of marker(s) or constituents with known therapeutic activity is not sufficient for the quality control of herbal medicinal products. Specific quality requirements include thorough product characterisation, adherence to the Good Agricultural and Collection Practices, good manufacturing practices and validated manufacturing process, e.g., raw material testing, in-process testing, fingerprint characterisation etc. Quality control of herbal medicinal products is primarily intended to define the quality of the herbal substance/preparation and herbal medicinal product rather than to establish full characterisation.

The legal framework governing the quality of (traditional) herbal medicinal products in the European Union

In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such a marketing authorisation are laid down in regulations, directives and scientific guidelines. This paper gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation.Pharmaceutical quality of medicinal product is the basis for ensuring safe and effective medicines. The basic principles governing the assurance of the quality of medicinal products in the European Union are primarily defined in the amended Directive 2001/83/EC and Directive 2003/63/EC. Quality requirements of herbal medicinal products are also laid down in scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in regulations and directives.Detailed quality requirements for herbal medicinal products on the European market are contained in European Union (EU) pharmaceutical legislation. They include a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community.The European regulatory framework encompasses specific requirements for herbal medicinal products. These requirements are independent from the legal status. Thus, the same quality standards equally apply to herbal products based on clinical evidence and traditional herbal medicinal products. The basic principle is that the quality of herbal medicinal products is intrinsically associated with the quality standard of the herbal substances and/or herbal preparations. Furthermore, the herbal substance or herbal preparation in its entirety is regarded as the active substance. Consequently, a mere determination of the content of marker(s) or constituents with known therapeutic activity is not sufficient for the quality control of herbal medicinal products.Specific quality requirements include thorough product characterisation, adherence to the Good Agricultural and Collection Practices, good manufacturing practices and validated manufacturing process, e.g., raw material testing, in-process testing, fingerprint characterisation etc. Quality control of herbal medicinal products is primarily intended to define the quality of the herbal substance/preparation and herbal medicinal product rather than to establish full characterisation.

Качество лекарственных препаратов. Суть вопроса и зарубежный опыт

Качество лекарственных препаратов. Суть вопроса и зарубежный опыт

Application of risk-based approach for determination of critical factors in technology transfer of production of medicinal products

Risk-based approach is used for examination of impact of different factors on quality of medicinal products in technology transfer. A general diagram is offered for risk analysis execution in technology transfer from pharmaceutical development to production. When transferring technology to full- scale commercial production it is necessary to investigate and simulate production process application beforehand in new real conditions. The manufacturing process is the core factorfor risk analysis having the most impact on quality attributes of a medicinal product. Further importantfactors are linked to materials and products to be handled and manufacturing environmental conditions such as premises, equipment and personnel. Usage of risk-based approach in designing of multipurpose production facility of medicinal products is shown where quantitative risk analysis tool RAMM (Risk Analysis and Mitigation Matrix) was applied.

DSC and IR as supporting tools for identification of methylxanthines in solid dosage forms of drugs

The purpose of this study was to learn, to what extent the DSC, FT-IR and Raman spectroscopy can be useful for evaluation of the quality of medicinal products, the composition of marketed pharmaceutical preparations. As many as twenty-seven commonly available medicinal products were chosen, of which the majority constitute the so-called over-the-counter drugs. As basic active pharmaceutical ingredients (APIs), the products contained methylxanthines: theophylline, diprophylline and caffeine. The study has shown that in many cases the three techniques can be useful for the detection of APIs in medicinal products. To reach this aim, well-shaped endothermic DSC peaks, appearing due to melting of the active constituents and the so-called matching factors of the FT-IR and Raman spectra related to those of API used as standards, were utilised. The results obtained by Raman spectroscopy were satisfying to a limited extent only. On the other hand, the matching factors were twice less effective than the results obtained by the FT-IR technique. In the case of the preparations with caffeine, the matching factors were several times less effective than those obtained by FT-IR. An exception to this rule are only medicinal products containing acetylsalicylic acid, whose matching factors were several times higher than those of FT-IR, but because of their low concentrations, it was impossible to detect the ingredient in the sample.

Specific features of medicines safety and pharmacovigilance in Africa.

The thalidomide tragedy in the late 1950s and early 1960s served as a wakeup call and raised questions about the safety of medicinal products. The developed countries rose to the challenge putting in place systems to ensure the safety of medicines. However, this was not the case for low-resource settings because of prevailing factors inherent in them. This paper reviews some of these features and the current status of pharmacovigilance in Africa. The health systems in most of the 54 countries of Africa are essentially weak, lacking in basic infrastructure, personnel, equipment and facilities. The recent mass deployment of medicines to address diseases of public health significance in Africa poses additional challenges to the health system with notable safety concerns. Other safety issues of note include substandard and counterfeit medicines, medication errors and quality of medicinal products. The first national pharmacovigilance centres established in Africa with membership of the World Health Organization (WHO) international drug monitoring programme were in Morocco and South Africa in 1992. Of the 104 full member countries in the programme, there are now 24 African countries with a further nine countries as associate members. The pharmacovigilance systems operational in African countries are based essentially on spontaneous reporting facilitated by the introduction of the new tool Vigiflow. The individual case safety reports committed to the WHO global database (Vigibase) attest to the growth of pharmacovigilance in Africa with the number of reports rising from 2695 in 2000 to over 25,000 in 2010. There is need to engage the various identified challenges of the weak pharmacovigilance systems in the African setting and to focus efforts on how to provide resources, infrastructure and expertise. Raising the level of awareness among healthcare providers, developing training curricula for healthcare professionals, provisions for paediatric and geriatric pharmacovigilance, engaging the pharmaceutical industries as well as those for herbal remedies are of primary concern.