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 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. 

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.

scholarly journals Regulatory Approval process for marketing drug in Japan

2021 ◽  
Vol 12 (2) ◽  
pp. 1081-1085
Author(s):  
Uma Maheshwari A ◽  
Kamaraj R
Keyword(s):  
Regulatory Authority ◽  
Research Work ◽  
Drug Approval ◽  
Regulatory Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Ministry Of Health ◽  
New Drug ◽  
Approval Procedure ◽  
Drug Approval Process

For the development of new drug, it requires a greater amount of research work in chemistry, Manufacturing, control, Preclinical and clinical trials. The drug approval process in all regulatory market carrying responsibilities on multiple factors such as data, safety, efficacy to public health in a country. Current constrain of affairs reveals diverse countries need to follow different regulatory requirements for Regulatory approval process for marketing drug in the different regulatory market of the country to ensure safety and efficacy of the product. In order to conduct a regulatory process for approval of a drug, every country has their unique regulation, guidelines, legislation and respective regulatory authority. Japan has its own regulatory authority for drug and medical device called the Ministry of Health, Labour, and Welfare (MHLW), Pharmaceuticals and Medical Devices Agency (PMDA), respectively. In the Japan Ministry of Health, Labour, and Welfare are overseeing the approval procedure of New drug, Generic Drug and Orphan Drug also. In that regard, the Drug Approval process followed in Japan ensures that every company has adhered to specific guideline available in their respective website. The drug comes to market with safety, efficacy to enhance the health of people in Japan by scrutinised process. It results into the longevity of human, which is so apparent in their demographic chart of Japan's Population.

Regulatory requirements and comparison in approval of new and generic drugs in United States of America and Japan:-Implication for Future strategies

2020 ◽  
Vol 07 ◽  
Author(s):  
Paramjeet Malik ◽  
Neelam Pawar ◽  
Kavita Bahmani
Keyword(s):  
Generic Drugs ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Team Members ◽  
Regulatory Authorities ◽  
Effective Manner ◽  
Review Team

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.

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.

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