Brazil ANVISA’s Regulatory Requirements for API

With the development of society and the improvement of medical level,the requirements of countries around the world for drugs,medical devices,and APIs used in drugs and devices are stricter year by year,which greatly guarantees the safety of drug production!

Brazil ANVISA's Regulatory Requirements for API

Let’s take a look at the regulation of API in the Brazilian market!

What is ANVISA?

Anvisa is an abbreviation from Portuguese Agência Nacional de Vigilância Sanitária,referring to the Brazilian Health Regulatory Agency.

The Brazilian Health Regulatory Agency(Anvisa)is an authoritarian agency related to the Ministry of Health,which is a part of the Brazilian National Health System(SUS)and the coordinating agency of the Brazilian Health Regulatory System(SNVS),and carries out work nationwide.

Anvisa’s role is to promote the protection and boundary of people’s health by controlling the production,marketing and use of products and services subject to health supervision,including relevant environment,processes,ingredients and technologies,as well as the control of ports and airports.

What are the requirements of Anvisa for importing APIs to the Brazilian market?

As for the Active Pharmaceutical Ingredients(IFA)in the Brazilian market,there have been some changes in recent years.Anvisa,Brazil,has successively promulgated three new regulations related to active pharmaceutical ingredients.

●RDC 359/2020 stipulates the Master Document for Drug Substance Registration(DIFA)and the Centralized Assessment Procedure for Drug Substance Registration(CADIFA),and the regulations cover the drug substances required for innovative drugs,new drugs and generic drugs;

●RDC 361/2020,revised the content related to raw material registration in the marketing application RDC 200/2017 and the post marketing change application RDC 73/2016;

●RDC 362/2020 specifies the requirements of the GMP Certificate(CBPF)and the requirements of the audit procedure for overseas API production facilities,including APIs derived from plant extraction,chemical synthesis,fermentation and semi synthesis;

The previous API registration(RDC 57/2009)will be invalid from March 1,2021,and will be submitted to Cadifa instead,thus simplifying some procedures for the previous API registration.

In addition,the new regulations stipulate that API manufacturers can directly submit documents(DIFA)to Anvisa even if they do not have agents or branches in Brazil.Anvisa has also prepared a document manual Manual CADIFA to guide international companies to submit applications.Guide each step of document submission.

From this point of view,Brazil Anvisa has greatly simplified the process of API document registration to a certain extent,and is also gradually increasing the supervision on API import.If you want to know about the Brazilian document registration,you can refer to these new regulations.

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Post time: Dec-30-2022