A critical appraisal of Japan's new drug approval process: a case study of FLT3-ITD inhibitor quizartinib

2021 ◽  
Author(s):  
Keisuke Kidoguch ◽  
Motoharu Shibusawa ◽  
Tetsuya Tanimoto
Keyword(s):  
Critical Appraisal ◽  
Drug Approval ◽  
Approval Process ◽  
New Drug ◽  
Drug 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.

The Drug Approval Process and the Information it Provides

1987 ◽  
Vol 21 (10) ◽  
pp. 821-826 ◽  
Author(s):  
Ann Myers ◽  
Steven R. Moore ◽  
Abraham G. Hartzema ◽  
Miquel S. Porta ◽  
Hugh H. Tilson
Keyword(s):  
Drug Administration ◽  
Drug Approval ◽  
Specific Information ◽  
Approval Process ◽  
The Public ◽  
New Drug ◽  
Drug Approval Process ◽  
Organizational Procedures ◽  
Abbreviated New Drug Applications ◽  
The U.S

By law, the commissioner of the Food and Drug Administration (FDA) is responsible for determining whether a new drug is safe and efficacious before it is approved for marketing in the U.S. and for monitoring its use after approval. This paper provides a brief overview of the approval process, in terms of responsibilities of the sponsor in submitting an application for review to the FDA and FDA's responsibilities and organizational procedures for reviewing and approving those applications. A brief history on the legislation regarding the FDA's responsibility in the drug approval area is discussed along with recent regulations, legislation, and FDA initiatives aimed at improving the drug approval process. Specific information that can be released to the public upon request is also discussed. This paper is limited to the regulation of drugs; somewhat different regulations govern the review and regulation of biological products and abbreviated new drug applications.

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 FOR US, EUROPE AND INDIA

2014 ◽  
Vol 2 (1) ◽  
pp. 1-11 ◽  
Author(s):  
Vishal Prajapati ◽  
Rahulgiri Goswami ◽  
Pratik Makvana ◽  
Jitendra Kumar Badjatya
Keyword(s):  
Drug Product ◽  
Research Work ◽  
Drug Approval ◽  
Research Data ◽  
Regulatory Agencies ◽  
Approval Process ◽  
The Public ◽  
New Drug ◽  
The World ◽  
Drug Approval Process

Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India. 

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