scholarly journals Regulatory advances and prospects of variation filing for the registered parenteral products in USA and Europe

2021 ◽  
Vol 9 (2) ◽  
pp. 52-65
Author(s):  
Rajdeep G. Makwana ◽  
Kuldeep V. Desai ◽  
Vaibhav Kikani ◽  
Maulikkumar D. Vaja
Keyword(s):  
Academic Research ◽  
Drug Approval ◽  
New Drugs ◽  
Regulatory Requirements ◽  
Complementary Medicines ◽  
International Agencies ◽  
Regulatory Affairs ◽  
Pharmaceutical Industries ◽  
Drug Approval Process ◽  
Parenteral Products

Drug Regulatory Affairs (DRA) is a vital unit in a pharmaceutical company. It is concern about the healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safety and efficacy in pharmaceuticals, veterinary medicines, medical devices, cosmetics and complementary medicines, healthcare products to individuals around the world. Regulatory affairs (RA) professionals are employed in pharmaceutical industry, government, academic research and clinical institutions. As India is growing very rapidly in pharmaceutical sector, there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. A regulatory affair is a somewhat new profession which has developed from the desire of governments to defend public health. Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Today 35 member countries along with 11 candidate countries and 4 international agencies have joined together to create the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to promote a globally accepted GMP. Current constrain of Regulatory Affairs reveals diverse countries need  to follow different regulatory requirements for  marketing authorization  Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and regulatory requirements according to US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organization (CDSCO).

scholarly journals A New Drug Approval Process in Europe: A Review

2019 ◽  
Vol 7 (3) ◽  
pp. 21-29
Author(s):  
Krishnasis Chakraborty
Keyword(s):  
Drug Approval ◽  
New Drugs ◽  
Marketing Authorization ◽  
Approval Process ◽  
Regulatory Requirements ◽  
New Drug ◽  
Regulatory Affairs ◽  
Drug Approval Process ◽  
Marketing Authorization Application

Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for Marketing Authorization Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and Regulatory requirements according to European Medical Agency (EMA) (1).

scholarly journals A review on drug approval process in US, Europe and India-dossier, bioavailability and bioequivalence studies

2017 ◽  
Vol 1 (04) ◽  
pp. 133-146
Author(s):  
Krishna Madagoni ◽  
Uppunuri Saidireddy ◽  
Himaja .
Keyword(s):  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Technical Documentation ◽  
Regulatory Requirements ◽  
Regulatory Decision ◽  
New Drug ◽  
Regulatory Affairs ◽  
Regulatory Approach ◽  
Drug Approval Process

Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and Development (RandD) efforts of the company to the market. In the present scenario, countries have different regulatory requirements for approval of a new drug. The single regulatory approach for marketing authorization application (MAA) of a new drug product applicable to various countries (on the basis of single dossier) is utmost difficult. Therefore, the knowledge of exact and detailed regulatory requirements for MAA of each country should be known to establish a suitable regulatory strategy. CTD was developed with the aim to provide a common format for the technical documentation that would significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and would ease the preparation of electronic submissions. Bioavailability and bioequivalence testing are essential in the drug development process as they create the foundation for regulatory decision making when evaluating formulation changes and lot-to-lot consistency in innovator products. They also serve as the primary components to demonstrate therapeutic equivalence between generic products and the reference innovator product. This article will focus the similarities and differences in drug approval process and requirements of the documents/CTD specifications to the drug regulatory authorities in the Europe, USA and India also focuses on submission and work flow related to bioavailability and bioequivalence studies.

scholarly journals Recent drug regulatory affair and CTD module progress review for submission of pharmaceuticals product

2021 ◽  
Vol 16 (3) ◽  
pp. 200-221
Author(s):  
Vaibhav Subhash Janjal ◽  
Snehal Ramdas Dhamodkar ◽  
Yogesh Pralhad Jadhao ◽  
Sima Baburao Manmode ◽  
Anil Keshav Pawar ◽  
...  
Keyword(s):  
Drug Approval ◽  
Regulatory Elements ◽  
Product Management ◽  
Complementary Medicines ◽  
Regulatory Affairs ◽  
Emerging Trends ◽  
Regulatory Strategy ◽  
Regulatory Bodies ◽  
Drug Approval Process ◽  
Pharmacy Curriculum

Regulatory Affairs (RA), also known as government affairs, is a relatively new profession that arose from governments' desire to protect public health by regulating the safety and efficacy of products such as pharmaceuticals, medical devices, pesticides, veterinary medicines, cosmetics, agrochemicals, and complementary medicines. Pharmaceutical regulatory affairs is concerned with the registration of pharmaceutical goods. All regulatory elements and guidelines connected to product filing are summarized in this evaluation. This study covers the whole CTD and eCTD submission process, as well as the modules that go with it. It also focuses on the key regulatory bodies across the world. Various roles of DRA departments, drug regulatory affairs professionals, the importance of drug affairs in pharmacy curriculum, emerging trends affecting regulatory strategy, regulatory affairs in product management, clinical trials, R&D and the drug approval process in the US, EU, and ROW market trends are discussed.

scholarly journals COMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND MARKETING AUTHORIZATION FOR MEDICINAL PRODUCTS IN EUROPEAN UNION AND ZIMBABWE

2018 ◽  
Vol 11 (10) ◽  
pp. 10
Author(s):  
Raju Kamaraj ◽  
Linda M Buruwe
Keyword(s):  
European Union ◽  
Comparative Study ◽  
New Drugs ◽  
Marketing Authorization ◽  
Medicinal Products ◽  
Regulatory Requirements ◽  
Regulatory Affairs ◽  
Comparison Results ◽  
Pharmaceutical Industries ◽  
Insight Into

The aim of this study is to evaluate the requirements for marketing authorization procedures of new drugs, generic medicines in developed countries such as Europe and to compare these procedures with those in developing countries such as Zimbabwe. Medicines control authority of Zimbabwe (MCAZ) grants the marketing authorization for medicinal products in Zimbabwe. However, there are still some gaps which need to be filled by the MCAZ to reach other bigger markets in the world. A comparative study of current MCAZ regulatory administration and practices with those of stringent regulators such as European Union will assist in the identification of these loopholes. It also provides the need for improvement with regard to pharmaceutical industries compliance with the relevant standards. This study will give a tremendous reassurance that the MCAZ regulatory affairs acquiescence is being met and gap analysis will systematically challenge the MCAZ regulatory requirements and procedures by comparing them to the European medicines agency regulatory guidelines, which will provide MCAZ with an insight into areas that have room for improvement. The study provides MCAZ with an insight into areas that have room for improvement. Current GMP Supervision of Manufactures and Inspections need to be upgraded; however, currently in Zimbabwe, there is inadequate internal audits, inadequate quality departments to do the validation and self-inspection in pharmaceutical industries. The comparison results obtained showed grey areas needed to be enhanced by MCAZ.

Business versus science: High drug prices conspire against oncological research.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14580-e14580
Author(s):  
Felipe G. Gercovich ◽  
Ernesto Gil Deza ◽  
Eduardo L. Morgenfeld ◽  
Marcelo Muino ◽  
Marvin Albert Mizrahi ◽  
...  
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Approval ◽  
Point Of View ◽  
New Drugs ◽  
New Drug ◽  
Drug Registration ◽  
Ethical Point ◽  
Post Marketing ◽  
State Of Affairs ◽  
Drug Approval Process

e14580 Background: It has been consistently proven that pivotal clinical trials (PCT) for drug registration or new drug indications (NDI), sponsored by the pharmaceutical industry, obtain better results than independent confirmatory studies (ICS). The interplay between PCT and ICS has supported better treatment selections and more realistic expectations: hope vs hype.The aim of this paper is to analyze the amount of ICS publications in Oncology within the last decade. Methods: All new FDA approved oncological drugs or NDI for solid tumors between 2005 and 2017 were taken into account. The PCT that led to their approval were identified, and between October and November 2019 a thorough search for related ICS (published or ongoing) was conducted on MEDLINE, ASCO Abstracts, NEJM, Lancet Oncology, JAMA, JCO, Cancer, PLOS ONE, PLOS Medicine and www.Clinicaltrials.gov. Results: Fifty-five new drugs or NDI were analyzed (Abemaciclib, Abiraterone, Ado-trastuzumab emtasine, Afatinib, Alectinib, Atezolizumab, Avelumab, Axitinib, Bendamustine, Bevacizumab, Brigatinib, Cabozantinib, Ceritinib, Cobimetinib, Crizotinib, Dabrafenib, Degarelix, Denosumab, Durvalumab, Eribuline mesylate, Everolimus, Ipilimumab, Irinotecan liposome, Ixabepilone, Lapatinib, Lenvatinib, Necitumumab, Neratinib, Nilotinib, Niraparib, Nivolumab, Olaparib, Osimertinib, Paclitaxel protein bound, Palbociclib, Panitumumab, Pazopanib, Pembrolizumab, Pertuzumab, Ramucirumab, Regorafenib, Ribociclib, Rucaparib, SipuleucelT, Sonidegib, Sorafenib, Sunitinib, Topotecan, Trabectedin, Trametinib, Trastuzumab, Vandetanib, Vemurafenib, Vismodegib, Ziv-afilbercept). Until November 30, 2019, no published or ongoing ICS were found in any of the cases. Conclusions: a) For the past decade, none of the PCT used for approval of new oncological drugs or NDI were replicated by ICS (without pharmaceutical industry sponsorship). b) We ignore the reasons for these approval methods but they raise suspicion and unnecessary discomfort. c) From an ethical point of view, patients’ Informed Consent must specify that expected results for the new drug or NDI are based exclusively on trials sponsored by the selling pharmaceutical company, unless other ICS are published. d) The current state of affairs can only be reverted if regulatory agencies and the scientific community demand ICS as part of the drug approval process or post-marketing duties.

Science: Part of the Problem, Most of the Answer

1983 ◽  
Vol 17 (7-8) ◽  
pp. 566-569
Author(s):  
Jere E. Goyan
Keyword(s):  
Small Businesses ◽  
Drug Approval ◽  
The United States ◽  
New Drugs ◽  
Great Debate ◽  
History Of ◽  
Drug Approval Process ◽  
Almost All ◽  
Small Manufacturers ◽  
Scientific Questions

The history of the drug approval process in the United States includes three phases. First, the Food and Drug Act of 1906 essentially required that the labeling of drugs be truthful. The 1938 Food, Drug, and Cosmetic Act added a requirement that drugs be proven safe, and the 1962 act added the requirement that drugs be efficacious. Each of these steps required more and more sophisticated science. Subsequent to the Kefauver-Harris Amendments of 1962, the number of innovative molecular entities each year has declined, the reasons for which have been subject to great debate. This decline has paralleled decreases in innovation across almost all American industry, leading to questions about the future of our country as an industrialized society. Both the Carter and Reagan administrations attempted to address this problem in a number of ways, including cutting back on those regulations that are perceived as unnecessary. Other innovative approaches have been used, such as the establishment of an Office of Small Manufacturers Assistance in the FDA Bureau of Medical Devices, mandated by the 1976 Medical Device Amendments. The latter came about in recognition of the fact that small businesses tend to be more creative and efficient than larger industries and more adversely affected by regulation. However, the problems raised in the regulation of technology transfer almost inevitably arise because of perceived scientific questions. Such questions, in turn, can only be answered by good science performed by the sponsor and understood by the regulator. Thus, it is essential that the FDA be staffed with knowledgeable scientists who can interact easily with their peers in academia and industry. Although science is often the cause of our troubles, it is also our only hope for minimizing the costs of new drugs and other technology. In turn, minimizing such costs will maximize the opportunities for innovation.

scholarly journals A comprehensive review on registration requirements for Drug Approval in India, South Africa and US

2021 ◽  
Vol 9 (1) ◽  
pp. 62-71
Author(s):  
Veer J. Patel ◽  
Dasharath M. Patel
Keyword(s):  
South Africa ◽  
Drug Product ◽  
Drug Approval ◽  
Drug Products ◽  
Technical Requirements ◽  
National Regulatory Authority ◽  
Regulatory Guidelines ◽  
Pharmaceutical Industries ◽  
Drug Approval Process ◽  
The Comparative Study

The drug approval process is country-specific. The regulatory framework of all the national regulatory agencies differ from one another in terms of administration and product specific guidelines for registration of drug and drug products in a particular country. Every national regulatory authority provides regulatory guidelines for drug or drug product registration and the pharmaceutical industries which rely upon these guidelines prepare drug applications along with all the required administrative, non-clinical and clinical data in the form of a technical dossier which is known as Common Technical Document. This Dossier is prepared either in an electronic format or in the paper submission format. This review focuses on the comparative study of the registration requirements for getting a drug approval in India, South Africa and United States of America. The significant differences between the technical requirements of these three markets have been discussed in detail.

scholarly journals Patient-Reported Outcome Labeling for Malignant Hematology Drugs Approved in the United States: 2011-2017

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2292-2292
Author(s):  
Marjorie E Zettler ◽  
Ethan Basch ◽  
Chadi Nabhan
Keyword(s):  
Drug Approval ◽  
The United States ◽  
Patient Reported Outcome ◽  
Health Condition ◽  
New Drugs ◽  
Approval Process ◽  
New Drug ◽  
Study Results ◽  
Patient Reported ◽  
Drug Approval Process

Abstract Introduction: Patient-reported outcomes (PROs), defined as any report on the status of a patient's health condition that comes directly from the patient without interpretation by anyone else, play an increasingly important role in drug development. In 2009 the FDA issued final guidance on using PRO measures to support labeling claims, to incorporate the patient perspective into the drug approval process. The 21st Century Cures Act emphasizes PROs as a differentiating element in the FDA approval process of new drugs, beyond traditional clinical outcome measures. Further, recent data has shown that intervention based on PROs can improve survival in metastatic cancers (Basch et al; 2017). The incorporation of PROs into the labeling of new drugs for malignant hematology disorders has not been studied and is the subject of this investigation. Methods: We reviewed the FDA's Novel New Drug Summaries (2011-2017) to identify drugs approved for malignant hematology indications. Drug approval packages and product labeling were accessed via the Drugs@FDA database and analyzed for PRO endpoints, measures, and labeling claims. Clinical trial designs and published study results were retrieved via the ClinicalTrials.gov website and PubMed. Results: Of 250 novel drugs approved by the FDA between 2011 and 2017, 22 (8.8%) were approved for malignant hematology indications. Interestingly, only 1 had PRO-based claims in their labeling, even though 13 of the 22 drugs (59%) collected PRO data in pivotal trials that led to their approval. Notably, the proportion of malignant hematology trials assessing PROs has increased over time, with 4 of the 5 drugs approved in 2017 for malignant hematology indications evaluating PROs in their development programs, compared with 9 of the 17 drugs approved in the preceding 6 years (80% vs. 53%). PROs evaluated included generic instruments such as the EQ-5D, and disease-specific instruments such as the EORTC QLQ-C30 (see table). Reasons cited for rejection of PRO data inclusion in drug labeling were single arm trial design, excessive missing data, statistical issues, and use of an inappropriate PRO instrument. Conclusions: While the FDA encourages PRO data submission as part of the new drug approval process, and although more than half of all malignant hematology drugs approved in the past 7 years assessed PROs during development, only 1 was able to successfully acquire labeling claims. Whether this is due to lack of PRO expertise on clinical development teams or absence of strong regulatory guidance on how best to implement PROs remains unknown and requires further research. Designing strategies to develop, validate and report PROs effectively is needed to meet regulatory requirements and enhance patients' voices in their own care. Table. Table. Disclosures Nabhan: Cardinal Health: Employment, Equity Ownership.

scholarly journals An overview on comparative study of registration requirements for generics in US, Canada and Europe

2020 ◽  
Vol 1 (4) ◽  
pp. 117-123
Author(s):  
Suryawanshi Meghraj ◽  
Jain minal
Keyword(s):  
Generic Drug ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Technical Requirements ◽  
Generic Drug Product ◽  
Similarities And Differences ◽  
Drug Approval Process ◽  
Country Specific

Generic Drug Product approval is most stringent and crucial process for company with different rules and regulation in different country. For the registration of the product company has to follow regulatory rules and requirement of country specific agency. Company should apply product marketing authorization as per norms of country requirements and should manage life cycle of that product throughout market. Need to understand and describe the various regulatory requirements for the generic drug approval process and comparison of regulated country. To understand the technical requirements required to market medicines in regulated pharmaceutical market. To evaluate similarities and differences within regulated market of U.S, Canada, and Europe. To understand and evaluate differences of post approval Changes within regulated market.

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