Skip to main content Skip to search Skip to main navigation

PIC/S: Brazilian ANVISA becomes member

As the PIC/S announced on 30 November 2020, the Brazilian National Health Authority 'Agência Nacional de Vigilância Sanitária' (ANVISA) has become the 54th member of PIC/S. 

ANVISA had already applied in October 2014. The on-site evaluation took place in October 2019, followed by the finalisation of the evaluation report in 2020. After that, the PIC/S audit team approved ANVISA's application. For the first time this was done in a written procedure and not as usual during a meeting of the committee dueto the Covid-19 situation. At the next virtual meeting of the PIC/S in January 2021 the organisation will give a special welcome to ANVISA.


Source:

PIC/S: Brazil / ANVISA joins PIC/S  

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

How is a QRM process initiated?

How is a QRM process initiated?

You can view the answer here:
Read more
FDA: Updated Pre-RFD Guidance for Combination Products

FDA: Updated Pre-RFD Guidance for Combination Products

The U.S. FDA has released an updated final guidance on preparing a Pre-Request for Designation (Pre-RFD), replacing the previous 2018 version. The revised document provides new recommendations for interacting with the Office of Combination Products (OCP) and clarifies expectations for Pre-RFD submissions.
Read more
EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs

EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs

The EDQM has introduced a modular training programme covering chemically defined active substances and medicinal products. It will take place between 1 and 12 December 2025.
Read more
 Data Integrity and Data Governance

Data Integrity and Data Governance

Data integrity is a key element in the pharmaceutical quality assurance system which has gained importance in recent years, especially from the viewpoint of the authorities. In GxP-regulated companies, managers are responsible for identifying and minimising risks to data integrity (“data governance”).

Read more
EMA Clarifies “Novel or Complex Manufacturing Process” Definition

EMA Clarifies “Novel or Complex Manufacturing Process” Definition

In its Quality of Medicines Q&A – Part 1, the EMA has clarified how “novel or complex manufacturing processes” should be interpreted for variation categories Q.II.b.1 (new/replacement finished product manufacturing site) and Q.II.b.4 (change in batch size).
Read more
EU: Environment Committee Comments on EU Regulation Regarding Critical Medicines

EU: Environment Committee Comments on EU Regulation Regarding Critical Medicines

The Environment Committee of the European Parliament has issued its opinion on the proposed EU Regulation to strengthen the availability of critical medicines. Key recommendations include fast-track permitting, simplified environmental assessments, and support for strategic manufacturing projects to boost EU production capacity.
Read more
Previous
Next