Registration Of Pharmaceutical Products Research Articles

Pharmaceutical Co-Crystallization: Strategies for Co-Crystal Design

Pharmaceutical co-crystal belongs to a subtype of crystal in which one component is an active pharmaceutical ingredient (API) and the other is coformer (generally regarded as safe GRAS). In the crystal lattice, the two components are hydrogen-bonded in a fixed stoichiometric ratio. Co-crystallization is a cheap and simple alternative to the presently available techniques of solubility enhancement and has gained much interest from the formulators during the recent few years. Because co-crystals can enhance the physiochemical properties of pharmaceuticals without affecting their therapeutic effect, the area of pharmaceutical co-crystals has reached a tipping point. Besides increasing solubility, some more applications of co-crystals have also been identified to enhance physicochemical properties like permeability, bioavailability, stability, tablet ability, etc. Co-crystals have been extensively studied in the literature, and there is a tremendous amount of literature on co-crystals. However, an exhaustive review of coformer selection and co-crystal regulation must be included. An effort has been made in the review to fill this void. The current study focuses on how co-crystallization can enhance the pharmaceutical characteristics of different drugs, besides giving an overview of the historical background and landmarks in discovering co-crystals. In this review paper, we have discussed the rational design of co-crystals and the selection of conformers for the synthesis of multi-component co-crystals, methods like H-bonding, PKa value, Synthonic engineering, Cambridge structural database, Hansen solubility parameter (HSP), etc as well as the IPR related details all across the world. There is an attempt to include reported works on co-crystals, which helps understand the concept. This review paper discusses pharmaceutical regulatory bodies in the US and Europe released guidelines that are highly useful for pharmaceutical product registration in these regions. Here, we also examine various commercially available pharmaceutical drug products. It also briefly predicts the future perspective of co-crystallization.

What makes joint assessment procedures attractive to the innovative industry: successes, challenges, and proposed improvements.

Regulatory harmonization and convergence have been identified as the key driver in promoting efficient evaluation of medicines, reducing workload, and supporting earlier access to medicines on the African continent. There has been great progress to date in enhancing regulatory harmonization and convergence on the African continent via the Regional Economic Communities (RECs) and with the establishment of the Africa Medicines Agency (AMA). In this article, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Africa Regulatory Network (ARN) presents its perspective based on the available literature review and results from a survey conducted with innovative biopharmaceutical companies to gather experiences using regional joint assessment procedures (JAPs) in Africa, such as the East African Community Medicines Regulatory Harmonization (EAC-MRH), the West African Medicines Regulatory Harmonization (WA-MRH), and the Southern African Development Community Medicines Regulatory Harmonization (SADC-MRH) initiative through the ZAZIBONA Collaborative Procedure for Medicines Registration (ZaZiBoNa), and provides best practices in this evolving landscape. The article also assesses other collaborative registration pathways available to facilitating registration of pharmaceutical products in African countries, such as WHO Collaborative Registration Procedures (CRP), Swissmedic's Marketing Authorisation for Global Health Products (MAGHP) and EU Medicines for All (EU-M4ALL). Benefits and challenges of each of the existing pathways are discussed in this article. Main benefits include building more expert capacity and improved collaboration amongst experts, as well as shorter review timelines in some cases. Key challenges include the lack of predictability in the adherence to procedural timelines as defined per guidelines, lengthy timeline to achieve national marketing authorization following joint assessment, the lack of dedicated personnel, administrative issues during the submission process as well as additional country-specific requirements on top of JAP-specific requirements. Our recommendations for improvements include harmonization of requirements across countries and regions and with international standards, appropriate resource allocation for JAP activities to ensure adherence to timelines, use of JAPs throughout the entire product lifecycle and all product categories, adequate use of digital technologies, and improved communication and transparency with applicants. These improvements will allow industry to better plan their filing strategies for the region which will lead to overall improved usability of the JAPs in Africa and enable faster patient access.

Use of Antialergic Medicines: Application of the DDD Methodology in Real Practice

Currently, the increase in the number of allergic diseases is considered as a global problem in many countries, including Kyrgyzstan. According to WHO data, allergic diseases are currently ranked 4th among the major chronic diseases in the world. Pharmacotherapy occupies an important place in the treatment of allergy symptoms. To study the use of antiallergic drugs, namely antihistamine and glucocorticoid drugs in real practice, we used the DDD methodology. The aim of the study: to study the use of antiallergic drugs in real practice in the Kyrgyz Republic using the DDD methodology. Materials and research methods. The materials of the study were the data of the Department of Medicines and Medical Devices under the Ministry of Health of the Kyrgyz Republic on the registration of pharmaceutical products in the Kyrgyz Republic, price lists and invoices of wholesale pharmaceutical companies and retail pharmacies in Bishkek. Research results. At the time of the study, the pharmaceutical market of the Kyrgyz Republic has a balanced range of drugs, including 184 trade names of the above groups of drugs, namely 98 antihistamines and 86 glucocorticosteroids. The calculation of the degree of consumption of antiallergic drugs was presented as the number of established daily doses — the number of DDD (NDDD) sold in 2021. Conclusion. Analysis of the obtained data showed that the first place in terms of volume of consumption in natural terms among glucocorticosteroids are drugs containing dexamethasone — 4077 DDD, the second place is occupied by betamethasone — 953 DDD and the third fluticasone — 641 DDD. The leaders in terms of antihistamines consumption were Diphenhydramine — 15320 DDD, Fexofenadine — 3100 DDD and Loratadine — 683 DDD.

Compressive Review on Role of ICH Guidelines in Registration of Pharmaceutical Products

The International Conference On Harmonization (ICH) Of Technical Requirements Is A Unique Project For Registration Of Pharmaceutical Products Which Are Intended For Human Use. This Brings Together The Regulatory Authorities Of Europe, Japan And United States And Experts From The Pharmaceutical Industry In The Three Regions To Discuss Scientific And Technical Aspects Of Product Registration.The Purpose Is To Make Recommendations On Ways To Achieve Greater Harmonization In The Interpretation And Application Of Technical Guidelines And Requirements For Product Registration In Order To Reduce Or Obviate The Need To Duplicate The Testing Carried Out During The Research And Development Of New Medicines.The Objective Of Such Harmonization Is A More Economical Use Of Human, Animal And Material Resources And The Elimination Of Unnecessary Delay In The Global Development And Availability Of New Medicines Whilst Maintaining Safe Guards On Quality, Safety And Efficacy And Regulatory Obligations To Protect Public Health. It Creates A Venue That Allows All Key Pharmaceutical Regulatory Authorities And Industry Stakeholders The Opportunity To Be More Actively Involved In Pharmaceutical Harmonization Work. It Aimed At The Standardization Of Requirements And Format Along With The Content Of Regulatory Documentation And Brings Down The Pressure On The Price Of Medicines By Enabling Greater Economies Of Scale And A Labelled Regulatory Playing Field. This Paper Is An Effort To Provide The Detailed Information About ICH Guidelines. Keywords: International Conference On Harmonization, Product Registration, Medicines, Pharmaceutical

Taxonomic Notes on the 'Mahat' (Artocarpus lacucha and A. thailandicus, Moraceae) Species Complex in Thailand.

‘Mahat’ is a well-known medicinal plant utilized in Thailand. The Thai name ‘Mahat’ has been used in many scientific articles for years. However, it is, unpredictably, a homonym of two scientific names in Flora of Thailand, i.e., A. lacucha and A. thailandicus. Additionally, both species are complex due to their high morphological variation. This causes difficulties in species identification especially when this Thai name is referred to as the scientific name for research publication, quality control of pharmaceutical raw materials, and registration of pharmaceutical products. In this study, we scrutinized the taxonomy of ‘Mahat’ by detailed examination of its morphology and distribution, including molecular and qualitative phytochemical studies. Leaf surfaces were inspected using scanning electron microscopy. The phylogeny of both species was studied using DNA sequences of nuclear and plastid regions. Chromatographic fingerprints, focusing on the major active compound oxyresveratrol, were identified using high-performance liquid chromatography. According to our current study, phylogenetic evidence showed that some samples of both species were clustered together in the same clade and phytochemical fingerprints were almost identical. These results are valuable data for taxonomic revision in the near future and reveal the possible utilization of A. thailandicus as a new material source of oxyresveratrol in the pharmaceutical industry.

МАРКЕТИНГОВАЯ ОЦЕНКА ПРЕПАРАТОВ, ПРИМЕНЯЕМЫХ В Г. БИШКЕК ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ, СВЯЗАННЫХ С НАРУШЕНИЕМ КИСЛОТНОСТИ

Objective: Marketing assessment of anti-ulcer medicines in pharmacies in Bishkek. Methods: The study was used by data from the Department of Medicines and Medical Technology at the Ministry of Health of the Kyrgyz Republic on the registration of pharmaceutical products in the KR – State Registry of Medicines and Medical Products of 2019, as well as price sheets and invoices of wholesale pharmaceutical companies and retail pharmacies in Bishkek. Results: Depending on the value of the turnover rate (TR), the drugs were divided into three groups: drugs with slow TR (0.5 < К < 1.0); drugs with constant TR (0.26 < К < 0.49); drugs with high TR (0 < К < 0.25). According to the results of studies, proton pump inhibitors and colloidal bismuth-based drugs are high-end drugs of TR. Conclusions: We have determined that the pharmaceutical market in Bishkek demonstrates incomplete saturation of anti-ulcer drugs from the total number of registered medicines. At the same time, the largest part of the range are drugs from the group of proton pump inhibitors. Keywords: Anti-ulcer drugs, proton pump inhibitors, marketing assessment, turnover rate.

A Forecast on Strategies for Regulatory Requirement of Drug Product Registration in African Pharmaceutical

Generics are playing a vigorous role in human health. As there is a widespread growth in population, demand for different disease types have also been increased and where drug players are concentrating for newest design, growth and profit. Pharmaceutical product registration is a strenuous task for emerging markets, and also for regulated markets. Although the need for pharmaceuticals and its registration have been standardised and harmonised by various International agencies and Health Authorities in the countries still many of the manufacturers face difficulties in getting their product approval which is due to many changes and constant amendments or changes in the process, rules, guidelines. It is compelling that all emerging markets of pharmaceutical industry should follow the regulatory requirements set, henceforth for the betterment of public health. This following is about the emerging market “Africa” registration process of its pharmaceuticals and brief on challenges faced for acceptance and its market. This review mainly aimed at the African pharmaceutical regulations which are required for the drug products registration, such as the pharmaceutical products and its evolution in the emerging market, the steps involved in the registration processes from the initial step till the final approval.

Role of ICH guidelines in registration of Pharmaceutical Products

The International Conference on Harmonization (ICH) of Technical Requirements is a unique project for Registration of Pharmaceutical products which are intended for human use. This brings together the regulatory authorities of Europe, Japan and United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
 The purpose is to make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.
 The objective of such harmonization is a more economical use of human, animal and material resources and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy and regulatory obligations to protect public health. It creates a venue that allows all key pharmaceutical regulatory authorities and industry stakeholders the opportunity to be more actively involved in pharmaceutical harmonization work. It aimed at the standardization of requirements and format along with the content of regulatory documentation and brings down the pressure on the price of medicines by enabling greater economies of scale and a labelled regulatory playing field. This paper is an effort to provide the detailed information about ICH Guidelines.

Regulatory requirements for preparation of Dossier for registration of Pharmaceutical products in ACTD & CTD format

To prepare and compile the Dossier required for Registration of Pharmaceutical Products as per the requirements of each countries which shall be acceptable internationally to develop one regulatory approach. To avoid variation in the documents submitted in the form of dossier for registration of Pharmaceutical Products in the different countries of the world it’s important to know the requirements of Regulatory Authorities of each countries in which the Dossier is filled for the smooth Registration. This agreed upon common format in the form of CTD format and ACTD format for the technical documentation will significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and will be more ease to submit the file having electronic database.

Regulatory Filing In Us and Eu: A Comparative View

Regulatory Affairs in pharmaceutical industry is dealing with all aspects of government affairs and to fulfill the requirements of Pharma regulatory agency of the concerned nations and deals with obtaining the approval from license, development of a pharmaceutical product to manufacturing,drug approval process and registration of pharmaceutical products for sale and distribution in different regulated markets and for post marketing studies. The pharmaceutical companies must adhere to the legislations that require drugs to be developed, tested, trialed, and manufactured in accordance to the guidelines so that they are safe and patient’s well - being is protected. This topic aims at reviewing about the basics of drug regulatory filing in pharmaceutical industry and to gain knowledge about the different aspects of introducing drug product(s) into USFDA/Europe regulated market.

Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development

Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.

PHP22 - Effect of the U.S.-Peru free trade agreement on Peruvian new Drug policies and the registration of Pharmaceutical Products

PHP22 - Effect of the U.S.-Peru free trade agreement on Peruvian new Drug policies and the registration of Pharmaceutical Products

OVERVIEW OF DRUG REGISTRATION REQUIREMENTS FOR PHARMACEUTICALS IN EMERGING MARKET

Pharmaceutical product registration is a demanding task in regulated, semi regulated and rest of world countries. Although the requirements are harmonized in regulated countries by CTD (Common technical document) filing, yet others have enormous diversity in requirements.ICH (International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) brought regulatory authorities and pharmaceutical industries of Europe, Japan and US together for various aspects of drug registration. Similarly, countries from Asia pacific and gulf are in process of harmonization with mutual concern as The Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC). The optimization in requirements is mandatory and can be judged by the incidence of higher cost involved in availability of drugs, research and development facilities. For better treatment safety and efficacy for the drugs must be justified and rationalize for public security. The quality, safety and efficacy data has its own importance in the registration dossier. The commercial significance of markets is increasing globally. It is vital for pharmaceutical industry to cope with the regulatory requirements for betterment of public and to ensure their place in the market. This paper approaches the registration requirements in the form a dossier for market authorization. It also has drawn a comparative statement on various approaches for harmonization of registration requirement for pharmaceuticals. Keywords: ASEAN, GCC, BMR, CIS, DMF, ICH, FP

Review of International Pharmaceutical Product Registration, 2nd ed.

Review of International Pharmaceutical Product Registration, 2nd ed.

Overview Of Stability Study Designs#

Stability requirements for the worldwide registration of pharmaceutical products have changed dramatically in the past few years. A series of guidelines on the design, conduct, and data analysis of stability studies of pharmaceuticals have been published by the International Conference on Harmonization (ICH); however, the statistical discussion on study design is limited. In this paper, stability designs including full, bracketing, and matrixing designs will be exemplified. The statistical aspects of these stability designs will be discussed in relation to the recent ICH guidelines. The statistical and regulatory considerations on the selection of stability design will also be presented. The stability study should be well designed so the shelf life of the drug product can be estimated with a high degree of accuracy and precision. Several commonly used criteria for design comparison will be presented. Finally, a case study is presented to illustrate the potential problems of an overreduced design from the statistical and regulatory perspectives. #The views expressed in this paper are the authors' professional opinions. They do not represent the official positions of the U.S. Food and Drug Administration.

Sample Size Requirements for Evaluation of Bridging Evidence

AbstractThis paper addresses issues concerning methodologies on the sample size required for statistical evaluation of bridging evidence for a registration of pharmaceutical products in a new region. The bridging data can be either in the Complete Clinical Data Package (CCDP) generated during clinical drug development for submission to the original region or from a bridging study conducted in the new region after the pharmaceutical product was approved in the original region. When the data are in the CCDP, the randomized parallel dose‐response design stratified to the ethnic factors and region will generate internally valid data for evaluating similarity concurrently between the regions for assessment of the ability of extrapolation to the new region. Formula for sample size under this design is derived. The required sample size for evaluation of similarity between the regions can be at least four times as large as that needed for evaluation of treatment effects only. For a bridging study conducted in the new region in which the data of the foreign and new regions are not generated concurrently, a hierarchical model approach to incorporating the foreign bridging information into the data generated by the bridging study is suggested. The sample size required is evaluated. In general, the required sample size for the bridging trials in the new region is inversely proportional to equivalence limits, variability of primary endpoints, and the number of patients of the trials conducted in the original region.

Importance of Trademark Protection for the Chemical and Pharmaceutical Industry

This article gives an overview of the marked shift which trademark protection has undergone during the past years. Burning trademark issues in the chemical and pharmaceutical area are parallel imports, central pharmaceutical product registration in the EU, counterfeiting, and Internet domain names.

The Globalization of Pharmaceutical Regulation

Drugs have long been among the most extensively regulated of all consumer products. Not only do all governments closely supervise virtually every aspect of their development, testing, production and marketing, but many also regulate their pricing and distribution. The pharmaceutical industry is highly globalized, with over half the sales of the fifty largest drug companies made outside their home country (Tarabusi and Vivkery 1993). However, until recently, drug regulation was virtually synonymous with national sovereignty. Firms were required to conduct separate tests, submit separate applications, and meet distinctive criteria to enter each national market.Because drugs are so extensively regulated and have such significant health and safety impacts, drug policy coordination has proven extremely difficult. Nonetheless over the last decade, national regulatory agencies have begun to cooperate more closely with one another. The European Union has established a centralized drug approval system, the United States Food and Drug Administration has become more willing to cooperate with its foreign counterparts, and the United States, the EU and Japan have made substantial progress in harmonizing drug approval requirements under the auspices of a new international body, the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Products (ICH). This article describes and assesses the implications of the increase in international coordination of national drug approval policies. It argues that the undermining of national regulatory sovereignty has improved both the effectiveness and efficiency of government regulation.

Documentation Handling within the Polish Registration System

The request for marketing authorization in Poland has to be submitted to the Bureau for Registration of Pharmaceutical and Medical Materials on the “Application for Pharmaceutical Product Registration. “ All documentation to be provided, in either Polish or English, is specified in the application form and includes experts’ reports. The procedure is tiered. The dossier is divided into three areas of expertise: chemistry and pharmacy, pharmacology-toxicology and clinical medicine, and drug information. The final report, consisting of summaries of the area reports, is scrutinized by the Registration Commission. Subsequently, following a positive decision the drug enters the process of quality testing and further documentation assessment. When the final assessment is ready, the Registration Commission makes a decision on registration. If the Registration Commission decision is negative an appeal may be submitted to the Minister of Health and Social Welfare by the applicant within 14 days. In general, the documentation is being processed on paper. Nevertheless, there are two existing databases: clinical trials and drug information. DAMOS, a registrational regulatory software package, is now being implemented in the registration system.

Book Review

Abstract Book reviewed in this article: Antimicrobial Susceptibility Testing. Critical Issues for the 90s, (Advances in Experimental Medicine and Biology/349) Edited by James A. Poupard, Lori R. Walsh and Bruce Kleger International Pharmaceutical Product Registration. Aspects of Quality, Safety and Efficacy Edited by A. C. Cartwright, B. R. Matthews Herbal Drugs and Phytopharmaceuticals. Edited by Norman Grainger Bisset Pharmaceutical and Biomedical Applications of Liquid Chromatography, (Progress in Pharmaceutical and Biomedical Analysis Volume 1). Edited by Christopher M. Riley, W. John Lough, Irving W. Wainer