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.
PIC / S is an initiative to modernize regulatory instruments, focusing on two main activities:
- International harmonization, through the establishment of reference guides in the area of Good Manufacturing and Distribution Practices for pharmaceutical products (GMP and BPD); and
- Conducting training to make inspection systems equivalent to good manufacturing practices from around the world equivalent.
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.
2019 was a crucial year in the process, as in this period the Agency did an intense job and of extensive discussion and updating of the regulatory instruments related to Good Practices in the Manufacturing of Medicines, as well as Public Health Laboratories, without forgetting the intense auditing work of State and Municipal Health Surveillance.
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.
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.
With the approval of ANVISA in the PIC / S, authorities from other countries can even recognize vaccine certifications when granted by Anvisa, facilitating the process in other countries.
Authors: Raissa Pinati do Nascimento and Sueli de Freitas Verissimo Vieira
