Switzerland acknowledges Anvisa inspection excellence

Brazil is on the verge of becoming a member of the Pharmaceutical Inspection Co-operation Scheme, which is expected to happen next year in the first semester. When it happens, a mutual acknowledgement between the inspections of Anvisa and SwissMedic must enter into force.

Published: 31 October 2019

Last Tuesday (Oct.10) Anvisa’s director Dr Antônio Barra and Swissmedic’s executive director, Dr Raimund Bruhin, signed in Rome a pilot project between the two regulatory authorities on inspection of good manufacturing practices for drugs and pharmaceutical ingredients.

Adopted in parallel with the International Coalition of Medicines Regulatory Authorities – ICMRA, that happened this week, the action stablishes a workflow for both institutions to materialize the recognition that the system inspections of both countries are equivalent. The project applies to all kinds of drugs (synthetic, biological, and phytotherapeutic drugs), including active pharmaceutical ingredients.

The pilot project must be carried out according to a decision tree. This kind of workflow paves the way for a mutual recognition from both sides. It will be the first Brazilian agreement of the sort, attesting the high level of Brazilian regulatory standards, which are compatible with those of the most competitive and advanced economies in the world.

In practical terms, the project will allow both regulatory authorities to verify, with the information provided by the counterpart, if the sanitary requirements have been met, with no need of a double inspection by both authorities, since it will already have been conducted by the local authority. However, if the information provided are not enough to decide whether the manufacturer should be certified or not, either Anvisa or Swissmedic may carry out their own inspections.

For Anvisa chairman, Dr William Dib, the project results from Anvisa’s recognition and it will help the population have access to quality drugs. It will also open the paths for other international collaborations, as well as extend the pharmaceutical market. “Anvisa is accomplishing its mission”, Dr Dib said.

In addition, according to director Fernando Mendes, “signing this project is the outcome of the efforts to harmonize and contribute to the discussions at international level. It definitely stimulates drug manufacturers located in Brazil to reach different markets”.

Background

In 2012, Anvisa and Swissmedic signed a Memorandum of Understanding. The discussion about the project itself started in 2018, when director Fernando Mendes took part of the ICMRA in Washington D.C., in the USA. During that meeting, Switzerland proposed the mutual acknowledgement regarding inspections of drugs and pharmaceutical ingredients conducted by each institution.

After evaluating the proposal, Anvisa considered the project to have a positive effect on both the national industry, that could export drugs more easily to Switzerland, and the Brazilian citizens, that could have quicker access to swiss drugs, with less inspection costs for the country. But before Anvisa and Swissmedic advance into the mutual recognition agreement, they designed a pilot project, as a necessary step to promote regulatory interchange and to expand the interaction and the partnership between the institutions. The project creates an information flow that helps to evaluate good manufacturing practices of companies located in both countries, intending to export their products respectively to Brazil or Switzerland.  

Swissmedic has been a member of the Pharmaceutical Inspection Co-operation Scheme PIC/S since 1996. Anvisa is on the last steps for joining the initiative. The process is expected to be concluded by April next year. The inspection systems of both countries have already been audited by the same criteria, in order to check and document the equivalence of the systems adopted by each institution.

Benefits  

The drug manufacturing profiles of Brazil and Switzerland are complementary. While Brazil has a consolidated industrial estate for the manufacturing of generic drugs, Switzerland stands out for its investments in innovation research and development. But both keep a rigorous sanitary control on drug marketing in both countries. Thus, the cooperation between the two regulatory authorities will bring concrete benefits to the populations and productive sectors of both countries.  

Concerning exports, there is a lot of room for improving participation, specially for generic drugs manufactured in national territory. In brief, the agreement with Swissmedic have the following benefits:

• Entry of drugs manufactured in Brazil into more competitive markets.
• Access to quality drugs.
• Reduction of double inspections carried out by two regulatory authorities.
• Saving of time, money and human resources.
• Importation and exportation processes will be facilitated.
• Reduction of the time to issue the certificate of good manufacturing practices, a necessary condition to register and market drugs in Brazil.
• More competitiveness and access to new technologies.
• Access to national and international drugs, with the same quality, safety, and efficacy standards.
• Quicker access to new technologies.
• Brazilian drugs will be put at the same quality levels of drugs manufactured in countries such as the United States, Canada, Japan, and European Countries.