Overview:

ANVISA  presents the requirements and reasons for rejection for the registration of Synthetic Drugs. The reasons included focus on quality and administrative aspects. Anvisa summarizes that the most number of rejections come from improper submission the following sections of the registration; Analytical Method Validation, Stability Study, Degradation Study and  Quality Control. 

Check out a GRP Presentation on the Registration of Generic Drugs in Brazil for a better idea on the Process and Requirements. 

Anvisa Definition of Synthetic Drugs:

The synthetic drug is a class of drugs produced by means of chemical reactions, and is easily replicable and allows the production of identical copy. Its molecules are small and the chemical structure is well known.  These drugs can be classified as new, generic and similar.

Synthetic Drug Registration Requirements:

1) Documents sent, but that need some clarification or additional testing, and can be answered in a timely manner (120 days); and

2) Doubts or requirements that are not clear in law, but that need proof for the quality of the drug.

Main Reasons for Registration Rejection from Anvisa:

1) Documents required in current regulations that were not sent;

2) Lack of response or inadequate response to the requirements.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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References:

Ministry of Health, Federal Government. Anvisa Section.

Brazilian Lymphoma and Leukemia Association. Drugs and their differences.  

More Resources:

Brazil’s ANVISA

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