Product Registration Research Articles

Tendencia al reemplazo de animales de experimentación

Para la aprobación, registro y comercialización de medicamentos, agroquímicos, productos de uso doméstico y sustancias cosméticas es necesario estudiar e informar al organismo regulador la potencial toxicidad. Por motivos éticos y económicos, en los últimos años se ha disminuido la utilización de animales de experimentación y se ha fomentado el desarrollo de metodologías alternativas. En el proceso de migración, la OCDE validó procedimientos para evaluar irritación y corrosión ocular y dérmica, mutagenicidad, fototoxicidad, sensibilización y absorción dérmica. Hoy en día es un área en constante investigación y desarrollo ya que aún no se ha logrado reemplazar completamente la calidad de los datos obtenidos en animales. Si bien la tendencia mundial al reemplazo de animales es clara, en Argentina aún no hemos dado el primer paso: no contamos con una ley que regule el uso de animales de experimentación. Las agencias reguladoras (SENASA y ANMAT) continúan solicitando ensayos con animales, pero han manifestado su interés en aceptar evidencia toxicológica obtenida por métodos alternativos. Desde el Laboratorio de Métodos Alternativos al uso de Animales de Experimentación que forma parte de la Plataforma Tecnológica EBAL nos hemos propuesto trabajar en el desarrollo, ejecución, perfeccionamiento y transferencia de metodología alternativa.

PMU107 INSIGHTS INTO REIMBURSEMENT RATES AND TIMELINES FOR ORPHAN DRUGS IN IRELAND

To gather insights into reimbursement rates and timelines for orphan drugs appraised by the National Centre for Pharmacoeconomics (NCPE). The European Commission's Community Register of orphan medicinal products for human use was cross-checked against appraisals on the NCPE website to identify orphan drugs that have been evaluated by the NCPE. The Health Services Executive (HSE) website was also searched for reimbursed drugs and cross-checked with NCPE assessments. The data from the identified evaluations were extracted and analysed in Excel. Between 2010 and 2019, 86 appraisals of 70 drugs were conducted by the NCPE. The majority were for non-cancer drugs (n=47, 54.7%) and in adults (n=58; 67.4%). Only 7 (8.1%) did not require a full pharmacoeconomic evaluation. In 18 (20.9%) instances the manufacturer did not provide a full pharmacoeconomic submission as requested. Of 68 completed appraisals, only 5 (4.7%) were positive recommendations, of which at least two required confidential price negotiations. The HSE approved another 34 drugs after confidential price negotiations (at least 22; 64.7%), the majority being cancer drugs (n=19; 55.9%). Average time from completion of the reimbursement process (either from the end of the Rapid Review or full pharmacoeconomic evaluation, whichever was the last assessment step) was 337 days (SD = 219) for cancer drugs, and 449 days (SD = 282) for non-cancer drugs. 8 drugs did not complete a full pharmacoeconomic evaluation, but was recommended by the HSE, on average after 495 days (SD = 330). Orphan drugs are extremely unlikely to be recommended by the NCPE, but are more likely to be recommended by the HSE. Manufacturers making submissions to Ireland should expect to discuss commercial discounts to secure reimbursement. Low positive recommendation rates by the NCPE, requirements for price negotiations and time to positive reimbursement with the HSE may deter manufacturers from making orphan drug submissions.

PENGUATAN KAPASITAS BUMG BERSAMA MINAPOLITAN MEURASA SABAN KABUPATEN ACEH TIMUR MELALUI EDUTEKNOPRENEURSHIP

Gampong-Owned Enterprises (BUMG) Minapolitan Meurasa Saban is a business entity owned by 5 villages (bale buya, matang gleum, kuala leuge, seuneubok peusangan and seuneubok pidie). with one of their business is BUMDES Mart Minapolitan Meurasa Saban. The weakness of administrative and financial as well as manual product registration are problems encountered in marketing the products on display at BUMG. The purpose of this program is to improve administrative and financial management staffs based on edutechnopreneurship. The activity was carried out for 5 months starting from May to September 2019. The activities involved 15 BUMG management and supervisors of Minapolitan Meurasa Saban. The method used is discussion and active participation of the target group by applying adult learning model. The activities were carried out in several stages which included coordination, socialization, training and mentoring activities. The results of the evaluation of the implementation of the activity showed that there was an increase in the capacity of BUMG's Bersama Minapolitan Meurasa Saban supervisors and management staffs on improving BUMG's administrative and financial governance. The results of the questionnaire showed that 10 administrators (75%) understood all the training material well, while 5 administrators (25%) understood all the training material. The level of satisfaction of the training participants showed 12 managers (85%) were very satisfied and 3 administrators (15%) were satisfied with the implementation of the training. BUMG Bersama Minapolitan Meurasa Saban supervisors and administrators have understood AD / ART and TUPOKSI, whereas the treasurer and operator of BUMG Bersama Minapolitan Meurasa Saban are able to understand the edutechnopreneurship-based product registration, BUMG Bersama Minapolitan Meurasa Saban has a business development plan as stated in the annual work programKey word: BUMG Bersama Minapolitan Meurasa Saban, Aceh Timur District, Edutechnopreneurship

SOME ASPECTS OF INTELLECTUL PROPERTY RIGHTS IN MEDICINE IN THE CONTEXT OF EUROPEAN INTEGRATION PROCESSES

The aim of the article is to analyze the objects of patent law in the field of medicine in the context of European integration processes. The field of medicine is quite speculative, it is about the life and health of people. As technology in the field of medicine improves, intellectual property rights become the privilege of medical companies, and technical organizations, etc. That is, we are talking about the fact that patents in our country are issued for everything. Today we seethat the policy of medical and pharmaceutical companies, according to the existing legal system in Ukraine, receives patents for inventions (utility models) and thus monopolizes the medical market, which in turn leads to a limitation of people to affordable drugs or available treatment services (patent for the method).The current state of the system of legal protection of inventions and utility models in Ukraine (patent system) is characterized by some problems. The legislation of Ukraine does not distinguish between objects covered by legal protection as inventions and utility models. In this regard, it is argued that securing the possibility of dual protection (patenting) of the same object as the invention or as a utility modelleads to a large number of patents that duplicate each other, has negative consequences for the realization of human rights in field of medicine.In this regard, we propose to bring the legislation of Ukraine into line with the European legislation by amending the Law of Ukraine «On Protection of Rights to Inventions and Utility Models» in Art. 6 «Legal Protection Conditions» are provisions that exclude medicinal products from among patentable utility models. At present, Ukrainian legislation allows the registration of a medicinal product on a utility model, which is inadmissible in the medical field. Such an opportunity creates favorable conditions for patent holders to monopolize the market and not to lower drug prices. Such legal protection of inventions is «evergreen patents» — patents whose holders artificially extendits exclusive rights to the active substance by providing protection to the additional properties of the active substance and methods of treatment. As for the industrial design, Article 5 of the Law of Ukraine «On Protection of Industrial Design Rights» provides legal protection for the industrial design, which does not contradict the public order, the principles of humanity and morality and meets the conditionsof patentability. An object of an industrial design may be the shape, drawing or coloring, or a combination thereof, which determine the appearance of the industrial product and are intended to meet aesthetic and ergonomic needs. We would like to draw attention to the fact that such industrial design patents as rubber stoppers are patent trolling and are an example of unfair use of intellectual property rights. Therefore, it is necessary to harmonize the patent legislation of Ukraine with the European Patent Convention.

Advances and Latest Insights in Non-Biologic Systemic Therapeutic Agents in Psoriasis and Atopic Dermatitis

Prof Peter van de Kerkhof, Radboud University Nijmegen Medical Centre, the Netherlands, discussed the very long history, particularly in Germany and the Netherlands, of dimethyl fumarate (a fumaric acid ester [DMF]) in treating psoriasis in adults. However, only recently, with a new DMF product registration in Europe, has clinical research escalated to investigate the most effective clinical use of this agent. Treatment strategies in patients with psoriasis should be personalised, with considerations of the disease, patient characteristics and preferences, as well as current and historical treatments. He presented a case scenario to highlight which patients might benefit most from DMF as a first-line systemic treatment for moderate-to-severe psoriasis. He further discussed the role of acitretin (a synthesised retinoic acid) as monotherapy in pustular psoriasis and erythrodermic psoriasis, and in combination for chronic plaque psoriasis. He concluded that in patients requiring systemic therapy with contraindications for immunosuppressive therapies, DMF and acitretin may provide a unique profile and treatment solution.

The PEPP Regulation (PEPPR): Pepper for the Capital Markets Union?

On June 20 th, 2019, Regulation (EU) 2019/1238 of the European Parliament and of the Council on the subject of a pan-European Personal Pension Product was adopted (hereinafter referred to as “PEPPR”). The object of the PEPPR is to lay down uniform rules on the registration, manufacturing, distribution, and supervision of personal pension products distributed in the European Union under the header of PEPP. This article will concentrate on how the PEPPR presents an added value for both PEPP savers and providers. Therefore, we explore the following: the legislative history and the reasons of the PEPPR, the definition of a PEPP, and its savers and providers. Furthermore, attention will be drawn to the investment options and the matter of consumer protection as well as the so-called “fee cap of 1 %.

Methods for Solving Environmental Problems in Livestock and Poultry Farming

In the Northwestern Federal District, the main agricultural source of environmental pollution is the disposal of organic waste (manure and litter), which accounts for a risk of 85 percent. The problem of ensuring environmental safety requires appropriate solutions based on modern intelligent machine technologies, means of monitoring and controlling technological processes of organic waste disposal. (Research purpose) To provide rationale for combined methods of solving environmental problems in animal and poultry farming. (Materials and methods) The authors studied the environmental impact of machine technologies used in livestock and poultry farming. The studies were carried out by assessing environmental risks and the sustainability of agroecosystems, applying methods and techniques for assessing the best available technologies, and studying the main prospects of developing intelligent digital technologies. (Results and discussion) The authors have identified the main methods of solving the environmental problems associated with large farm enterprises, including the calculation, design and system operation of the best available technologies for agricultural production. They have proposed a technical tool in the form of a bioreactor for the disposal of organic waste, capable of reducing manure and litter processing period in 60 times and providing automated flow and process control with online registration of production and environmental indicators. They have described an intelligent system for monitoring and utilizing organic waste, including a conceptual framework for establishing modular centers for deep processing. (Conclusions) The authors have proved that the implementation of modern methods for ensuring effective and environmentally safe agricultural production requires the establishing of experimental plot sites for complex research and demonstration of a “machine technology – monitoring – management” system. It has been proposed that a site of the VIM agrobiotechnological cluster should be established at a pilot livestock complex enterprise in the Leningrad Region. The authors have identified promising areas of research to ensure the transition of agricultural production to a new technological structure that implements the principles of Smart Farming to provide for the disposal of at least 510 million tons of agricultural organic waste a year.

The Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities.

In relation to the registration of generic products, waivers of in vivo bioequivalence studies (biowaivers) are considered in three main cases: certain dosage forms for which bioequivalence is self-evident (e.g. intravenous solutions), biowaivers based on the Biopharmaceutics Classification System and biowaivers for additional strengths with respect to the strength for which in vivo bioequivalence has been shown. The objective of this article is to describe the differences and commonalities in biowaivers for additional strengths of immediate release solid oral dosage forms between the participating members of the International Pharmaceutical Regulators Program (IPRP). The requirements are based on five main aspects; the pharmacokinetics of the drug substance, the manufacturing process, the qualitative and quantitative composition of the different strengths, and the comparative dissolution profiles. For the pharmacokinetic aspects, many regulators/agencies have the same requirements. All strengths must be manufactured with the same process, although a few regulators/agencies accept small differences. In relation to the formulation aspects, the data required breaks down into three major approaches based initially on one of those of the EU, the USA or Japan, but there are some differences in these three major approaches with some country specific interpretations. Most regulators/agencies also have the same requirements for the dissolution data, though there are some notable exceptions.

Проблеми правового регулювання спрощеної реєстрації ветеринарних препаратів в Україні

Статтю присвячено дослідженню особливостей правового регулювання спрощеної реєстрації ветеринарних препаратів у світлі гармонізації законодавства України із законодавством ЄС. Відзначено, що у зв’язку зі складністю підготовки повного реєстраційного досьє в законодавстві багатьох країн, в тому числі країн Євросоюзу передбачено низку можливостей для спрощеної реєстрації ветеринарних препаратів шляхом подачі скороченого переліку матеріалів реєстраційного досьє.
 Здійснено аналіз відповідного законодавства ЄС, зокрема положень Директиви 2001/82 щодо спрощеної реєстрації ветеринарних препаратів. Визначено, що в праві ЄС передбачено можливість подачі неповного досьє у випадках реєстрації генеричних чи гібридних ветеринарних препаратів, ветеринарних препаратів з добре вивченим ветеринарним застосуванням, ветеринарних препаратів з фіксованою комбінацією, ветеринарних препаратів, що реєструються за інформованою згодою. Доведено, що на сьогодні правове регулювання такої реєстрації в Україні потребує вдосконалення.

Comparative study of Regulatory requirements of Drug Product in Emerging market

Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exist in clusters with their mutual concern. The optimization and harmonization requirements has become mandatory and can be examined by the incidence of higher cost involved in availability of drugs, quality requirement of premise and research and development, regional registration requirements. Quality, Safety and Efficacy data has significance importance in dossier registration. Pharmaceutical Industries has to comply with regulatory requirement in Emerging market and for betterment of public Health and safety.The review also explains a brief about different regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier application in Emerging market.

Development of new TB regimens: Harmonizing trial design, product registration requirements, and public health guidance.

Christian Lienhardt and colleagues discuss the importance of communication and coordination between regulators, researchers, and policy makers to ensure tuberculosis trials provide high-quality evidence for policy decisions.

Regulatory Requirements and Innovation: A Comparison of the Dermatologic Antifungal Drug Product Markets in Brazil and United States

Development of novel dermatological topical products for the treatment of cutaneous fungal infections is a constant necessity, especially in developing countries. Through public health policies, many developing countries have facilitated in the last decades the entry of generic products, which can be superficially seen as a threat to innovation. To verify whether regulatory requirements, or the waiving of some requirements, could have an impact on innovation, we performed a detailed technical comparison of the dermatologic antifungal markets of Brazil and of the United States, taking Brazil as an example of a developing country with more lenient requirements regarding the registration of generic topical drug products. The official databank of ANVISA (DATAVISA) and of US Food and Drug Administration (Orange Book) were assessed for valid topical dermatological antifungal drug products registered. The Brazilian market has a greater number of registered drug products encompassing a greater variety of drug substances than the US, but the latter comprises more products with novel technologies. In both countries, cream was the predominant dosage form and imidazoles were the major substance group. Ketoconazole was the lead active substance in Brazil and ciclopirox was the lead drug in the US. Generic products dominated both markets. Despite the great number of registered products, the Brazilian market lacks the latest technologies, reflecting that the ease of generics registration is not accompanied by innovation.

Türkiye’de Coğrafi İşaretli Gıda Ürünlerinin Gurme Turizmi Açısından Önemi

Türkiye çok sayıda coğrafi işaretli gıda ürünleri ile (Aydın inciri, Malatya Kayısısı, Erzincan Tulum Peyniri, Hatay Künefesi, Giresun Fındığı, Malatya Kayısısı, Kayseri Pastırması, Çorum Leblebisi, Maraş Biberi, Maraş Dondurması, Ezine Peyniri, Ayvalık Zeytinyağı gibi) gurme turizmi açısından önemli bir potansiyeline sahiptir. Almanya, Fransa, İtalya ve İspanya gibi ülkeler ise gurme turizminin geliştiği ülkeler arasında yer almaktadır. Bu ülkelerde de gurme turizmi kapsamında çikolata, zeytin, zeytinyağı ve peynir gibi yöresel gıda ürünlerine özgü gurme turizm faaliyetleri yapılmaktadır. Söz konusu yöresel ürünlerin bir çoğu coğrafi işarete sahiptir. Coğrafi işaretli ürünler, tüketiciye ürünlerin kalitesi ve spesifik özellikleri hakkında standart sağladığı için, bu ürünlerin üretildiği bölgeler turizm açısından da cazip hale gelebilmektedir. Bu çalışmanın amacı, Türkiye için, coğrafi işaretli gıda ürünlerinin, turizm faaliyetlerinin çeşitlendirilmesi ve turizm gelirlerinin arttırılmasında önemli olan gurme turizmi açısından incelenmesidir. Coğrafi işaretli gıda ürünleri gurme turizmi kapsamında bir kırsal kalkınma aracı olarak kullanılabilmektedir. Yöresel gıda ürünlerinin üretildikleri bölgelerdeki küçük işletmelerin ekonomik sürdürülebilirliğine yaptığı katkılar yerel ekonominin canlandırılmasını sağlamaktadır. Ekonomik katkılar istihdam nedeniyle pozitif sosyal sonuçlar da yaratabilmektedir. Bu nedenle, coğrafi işaretli gıda ürünlerinin üretimi teşvik edilmeli ve gıda politikaları içerisinde ele alınmalıdır. Bu çerçevede, yerel kalkınmada rol oynayabilecek ve gurme turizmine katkı yapma potansiyeli olan gıda ürünlerinin coğrafi işaret süreçleri desteklenmelidir. Her şeyden önce, gıda ürünlerinin ekonomik, sosyal ve çevresel katkılarının değerlendirildiği bilimsel çalışmaların yapılması yararlı olabilecektir.

Identification and Synthesis of a Nitrophenyl Metabolite of Rinskor Active from Terrestrial Aerobic Soil Studies

To support the registration of crop protection products, over 100 regulatory studies are conducted for an active ingredient. These studies allow regulatory agencies and the agroscience industry to ...

CATALYSTS OF ACID-BASE PROCESS ON THE BASIS OF THE MODIFIED CARBON FIBER

The functionalization of the carbon fiber based on polyacrylonitrile with sulfur-containing groups of high acidity was carried out in order to obtain the acid-base processes catalysts. Fibers were treated with sulfur vapors in the temperature range of 400-800°C, followed by surface oxidation with 30% hydrogen peroxide solution. Modified samples were investigated by chemical analysis, thermo-programmed desorption with mass spectrometric registration of products, IR spectroscopy and thermogravimetry. It is shown that the obtained materials contain SO3H-functional groups and oxygen-containing groups (carboxyl, lactone, phenolic, etc.) formed in the surface layer during the oxidation of the fiber surface. The chemical analysis showed that the concentration of sulfur in the samples of the modified fiber is 1.6-6.5 mmol/g. The synthesized samples have a satisfactory thermal stability.
 The synthesized catalysts were investigated in the model reaction - gas phase dehydration of isopropyl alcohol. It was found that obtained SO3H-containing carbon fibers were catalytically active and had high propylene selectivity. For all the samples obtained there is a complete conversion of alcohol into propylene. The activity of modified carbon fiber samples in the reaction indicated is a fairly high, temperatures of the total conversion of alcohol into propylene are in the range of 160-190°C. During the study of synthesized catalysts in several cycles of catalysis it have been shown that within repeated use (3 cycles) of all modified fiber samples, the yield of propylene does not decrease, the activity remains stable - the temperature of the dehydration reaction remains unchanged or increases insignificantly (by 5-10ºС). The temperatures of complete conversion of isopropyl alcohol in propylene for synthesized catalysts are lower than the temperatures of destruction maxima of surface sulfogroups. Thus, modified carbon fibers can be used as low-temperature catalysts of acid-base processes, in particular dehydration of alcohols.

Time to Explore Pharmacy Career Opportunities in the Private Sectors

Pharmacy is a dynamic healthcare profession that allow role expansion into patient-care, manufacturing, management as well as entrepreneurship. The private sector provides a lucrative and promising platform for budding young pharmacists to build their career in healthcare. Apart from training opportunity and room for salary increment, the career pathway for a pharmacist in private practice is also diverse and bright. Fresh pharmacy graduates should explore this established career pathways. First, the growing number of private hospitals and role expansion of the pharmacist directly increases the demand of pharmacists in these private hospitals. Second, pharmacists are also a core team member in the pharmaceutical industry including the manufacturing sector not just because of the law requirement but also their expertise in formulation, production quality control, drug analysis, product registration and Good Manufacturing Practice (GMP). Third, the community pharmacy also provides a high potential platform to expand a young pharmacist’s entrepreneurial skills, along with the role as a clinician and primary healthcare provider. Across Ministry of Health facilities as well as private healthcare, the pharmacist’s roles are transitioning from product-focus to direct patient care. The shift to patient medicine management has long been successfully implemented in developed countries, including Singapore and Australia, both at public and private facilities. The private sector, arising from the holistic and multiplicity nature of practice, is certainly as rewarding and job-satisfaction fulfilling as the public sector because the pharmacists interact in their multifaceted role as dispenser, clinician, retailer, entrepreneur and primary health advisor. Key words: Work Satisfaction, Pharmaceutical Industry, Career Choices, Public Service.

Digital Breast Tomosynthesis Mammography System Registration Application Data Technical Review Concerns

In this paper, the focus of technical review of the registration application data of digital Breast Tomosynthesis Mammography System was sorted out, so as to provide reference for researchers and manufacturers in China when applying for registration and preparation of such products.

Regulatory Aspects of Traditional Indian Medicines (TIM) in India and in International Purview

Background: Regulatory affairs play a crucial role in the pharmaceutical industry and are incorporated in all stages of drug development. Objective: Approval criteria practices were developed as a resolution of the government's desire to create policies to protect public health by controlling the safety and efficacy of merchandise in areas including pharmaceuticals, complementary color medicines, veterinary medicines, medical devices, and even food products and cosmetics. Method: Herbal health products are in practices in all parts of the world under either their legal system's or expert council's or agencies' guides. They include botanicals, health supplements, health foods, complimentary medicines, traditional medicines or following pathies like Ayurveda, Yoga, Unani, Siddha, and Homeopathy. The requisite parameters for registration or recognition of products by various major global regulatory agencies were reviewed, and compiled under purview. Results: In India, licensing these products is under the act provisions and the rules known as the Drugs and Cosmetics Act, whereas globally regulatory provisions follow the guidelines of developed countries like the U.S. Food and Drug Administration, European Medicines Agency, the Therapeutic Goods Act, or the World Health Organization's regulations for herbal products. Conclusions: The present communication highlights the provisions of regulatory and/or licensing requirements related to corporates, product composition, specifications, quality parameters, manufacturing methodology, stability, safety, preclinical studies, clinical studies, etc. for herbal products and the respective guidelines at one site. Highlights: Ultimately, all regulatory agencies across the world highlight majorly the safety and thereafter the efficacy for any products under the category.

Abstract 4457: Open science medicinal chemistry: Towards a treatment for DIPG

Abstract Meds4Kids Pharma (M4K)1 is pioneering an open science approach to drug discovery, focussed on the discovery and development of small molecule therapeutics for orphan paediatric cancers. M4K seeks to test the hypothesis that an open science framework can be successfully applied not only to accelerate basic science, using the collective knowledge of the scientific community at large, but also to take an innovative new drug candidate all the way from discovery and clinical proof-of-concept through to product registration, by making use of regulatory data protections and market incentives. Since late 2017, Charles River Early Discovery has been providing in kind drug discovery services to help progress these efforts, including medicinal and synthetic chemistry. The first M4K project aims to generate an orally-available, brain-penetrant therapeutic to treat the diffuse intrinsic pontine glioma (DIPG). DIPG is a rare, aggressive and uniformly fatal childhood brain cancer with a median survival time of 9-12 months and for which there are currently no effective drug treatments. The disease has been shown to be associated with mutations in the ACVR1 gene (activin A receptor, type 1) also known as ALK2 kinase. Early support for the therapeutic hypothesis that an inhibitor of ALK2 kinase would have clinical benefit in DIPG, came from in vivo studies with non-selective ALK2 kinase inhibitors, which both killed DIPG cell lines harbouring the ALK2 mutation and extended lifespan in xenograft mouse models.2 Working collaboratively with M4K and their open science partners, we have made excellent progress towards the identification of potent, selective, brain penetrant ALK2 inhibitors starting from the known inhibitor LDN-214117, previously described for FOP (fibrodysplasia ossificans progressiva).3 Our current lead compound has an excellent in vitro and in vivo profile showing high oral bioavailability and brain penetration in a mouse PK study and is progressing to proof of concept studies. In addition we are progressing with the identification of a back-up series.

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.