FDA calls for enquiry into industry influence during Alzheimer's drug approval process

2021 ◽  
Vol 883 (1) ◽  
pp. 32-32
Keyword(s):  
Drug Approval ◽  
Approval Process ◽  
Drug Approval Process

COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND BRAZIL

2016 ◽  
Vol 4 (2) ◽  
pp. 1-9
Author(s):  
Lincy Joseph ◽  
Mathew George ◽  
Kalpesh K Malaviya ◽  
Kalpesh K Malaviya ◽  
Bincy K Chacko ◽  
...  
Keyword(s):  
Generic Drug ◽  
Drug Approval ◽  
Evaluation Agency ◽  
Approval Process ◽  
Registration Process ◽  
Regulatory Guidelines ◽  
Food Drug Administration ◽  
Government Websites ◽  
Drug Approval Process ◽  
Regulatory Sites

This aims to compare the generic drug approval and registration process in the regulatory market of Europe, USA andBrazil. Based on the information collected from various sources such as regulatory sites, Government websites,discussion with regulatory agent, interviewing pharma professionals and literature survey from various journals, aclear picture on the generic drug approval and registration process of each country was drawn. The differentauthorities’ viz. European Medicines Evaluation Agency (EMEA) of Europe, Food Drug Administration (FDA) ofUSA and National Health Surveillance Agency (ANVISA) of Brazil carried out the generic drug approval andregistration process in the respective countries. After analysing the various requirements for the generic drug approvalin the above stated countries, it was concluded that the regulatory guidelines of Europe and Brazil was not welldefined. But FDA gives very much well defined requirements. 

MARKETING AUTHORIZATION OF GENERIC DRUG: GLOBAL ISSUE AND CHALLENGES

2013 ◽  
Vol 1 (3) ◽  
pp. 1-6
Author(s):  
Pankaj Kashyap ◽  
Eshant Duggal ◽  
Parveen Budhwar ◽  
Jitendra Kumar Badjatya
Keyword(s):  
Generic Drug ◽  
Patent Protection ◽  
Drug Approval ◽  
Approval Process ◽  
Generic Medicines ◽  
Healthcare Provision ◽  
Pharmaceutical Markets ◽  
Global Issue ◽  
Drug Approval Process ◽  
High Level

Generic medicines are those whose patent protection has expired, and which may be produced by manufacturers otherthan the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost savingmeasure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Theobjective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory andlegislative level, from originator medicines. It describes the current and historical regulation of medicines in theworld’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between genericsand their originator equivalents including the reasons for the cost differences seen between originator and genericmedicines. This article refers to the general generic drug approval process in India, USA, and Japan. They havedifferent regulation and approval process. 

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.

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