Brazil- Anvisa

Overview:

The National Health Surveillance Agency (ANVISA) has completed the process of joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The Agency will become the 54th member of the international pharmaceutical inspection initiative and will now have the international recognition of excellence in Good Manufacturing Practices (GMP) inspections of drugs and pharmaceutical inputs for human use.

By formalizing its interest in becoming a member of PIC/S, the Agency was willing to begin efforts to modernize its regulatory framework, invest in the qualification of inspectors who work in the National Drug Inspection System, and harmonize the inspection procedures of good manufacturing practices for drugs in all Brazilian states.

ANVISA’s Audit:

In October 2019, the country received PIC/S inspectors, members of the health agencies of the United Kingdom, Portugal, Malta and Hong Kong, who audited Anvisa for the certification that the Brazilian inspection process is equivalent to that of the other PIC/S member countries.

Regulatory Corner:

The benefits of being a member of PIC/S  are:

  • The drugs produced in PIC/S member countries are perceived as of quality, as they are supervised by a health authority considered equivalent to the main ones in the world;
  • Ease in the export process to some countries that accept the certification of regulatory authorities that are members of PIC/S;
  • Increased access to markets;
  • Harmonization of Good Manufacturing Practices;
  • Adoption of High Standard Guides, with periodic evaluations of both the regulatory framework and the performance of PIC/S regulatory authorities;
  • Participation in the PIC/S Rapid Alert and Recall System;
  • Increased international recognition and credibility of the Agency’s decisions.

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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