ANVISA of Brazil received the approval to become a member of PIC/s (Pharmaceutical Inspection Co-operation Scheme) in November 2020. Considering the pandemic situation, for the first time in PIC/s history, the assessment was completed in a written procedure as opposed to at a meeting; on Jan 1, 2021, the PIC/s committee welcomed ANVISA as their 54th valuable member.

The other 53 members of PIC/s come from 50 nations worldwide. As the PIC/s guide is used for both human and veterinary medicines, some countries have multiple authorities as a member/member authority.

The process of becoming a member usually takes 4-5 years and consists of two stages – Pre-application & Application. It demands the Health Authority to undergo an extensive elevation in its system & procedures. Also, to complete the checklist of standards specified by PIC/s to reach the level of standards of the current member authorities. Obtaining the approval of membership reflects that ANVISA has satisfied all the expectations of PIC/s by uplifting its legislation, inspection procedures, Quality System, inspector training, etc., and is obliged to maintain the same.

With the membership of PIC/s, there will be a lot of instrumental advantages. ANVISA will experience considerably enhanced credibility and recognition on a global level. Added advantages like regular assessments of Regulatory framework & performance, training opportunities, involvement in PIC/s Rapid Alert & Recall System, simplicity in closing bilateral agreements will help ANVISA in retaining the global GMP standards.

Along with the health authority, the health industry will also enjoy a fair number of advantages. Adopting PIC/s codes will reduce duplication of inspections, save time & financial resources, increase export and eventually open access to greater markets.

Also, the drugs produced in a member country will be considered a quality product and holding a GMP certificate approved by PIC/s will no longer require thorough evaluation and inspection, enabling fast approval of the product. Taking the COVID-19 situation into account, ANVISA, as a member of PIC/s helps in emergency vaccine approvals, which is the biggest advantage to the Brazilian health care industry.

Brazil is the leading pharma market in Latin America and the 6^th largest market globally. Acceptance as a member of PIC/s will open endless opportunities in the Brazilian pharma sphere. If you are looking for any regulatory assistance in Brazil, you can always opt for an expert. Stay informed. Stay updated.