New GMP regulatory framework approved

Norms allow the population safe access to medicines and will improve the regulatory framework of Brazil, according to international reference standards, improving the competitiveness of the national industry.

Anvisa’s Board of Directors approved, on Tuesday (8/20), the new regulatory framework for good manufacturing practices (GMP) for medicines in Brazil. The Good Manufacturing Practices Regulation is the main regulatory standard to guarantee the quality of medicines in the country.

With the approval, the Agency updates the current Resolution of the Collegiate Directorate (RDC) and 14 Normative Instructions on the subject, allowing the population safe access to medicines and improving the regulatory framework of Brazil, according to international reference standards. The new rules make it possible for Brazil to expand drug exports to the largest pharmaceutical markets in the world. Thus, the country becomes more competitive in this pharmaceutical market of giants, enabling its affiliation to the Pharmaceutical Inspection Co-operation Scheme (PIC / s).

Benefits

For the CEO of Anvisa, William Dib, as the pharmaceutical industry is responsible for the development, production and commercialization of medicines, its importance for the country is indisputable. “The new regulatory framework approved by the Agency puts Brazil on an equal footing for access and expansion of the pharmaceutical market, in addition to favoring the population’s access to quality medicines,” says Dib. And he concludes: “It is Anvisa fulfilling its mission”.

The director Fernando Mendes, reporter of the article, also pointed out that “the increase in the quality of medicines provided by the update of the GMP regulatory framework directly benefits Brazilian consumers”. According to him, “the impact of the update is added to the efforts to harmonize and contribute to discussions at the international level and decisively impels drug manufacturers located in Brazil to access different markets”.

Medicines market

Currently, 85% of generic drugs consumed in Brazil are of national origin and almost 9% are produced in India. With the update of the GMP regulatory framework and the matching of requirements to those of the PIC / s, Brazilian manufacturers may come to recover this 9%, considering that potentially these Indian companies do not comply with the most modern regulatory frameworks of quality of manufacture of medicines . Thus, it is believed that Brazil, as a member of the PIC / s, will become a more attractive and competitive market.

It is estimated that pharmaceutical revenues worldwide have already exceeded US $ 1 trillion. The USA is responsible for most of these revenues, due to the leading role of the American pharmaceutical industry. However, as in many other sectors, the Chinese pharmaceutical sector has shown high growth rates.

PIC / sec

Today, PIC / s has 57 members from 47 countries. Cooperation is aimed at both medicines for human use and veterinary medicines, and therefore some countries have more than one member authority.

Each country, even with two affiliated institutions, has the right to one vote and all decisions are made by consensus. The regulatory authorities of the following countries are members of PIC / s: Argentina, Australia, Austria, South Africa, Belgium, Canada, Croatia, Cyprus, Spain, Slovakia, Denmark, Czech Republic, France, Slovenia, Germany, Finland, Estonia, Greece, Iceland, Hong Kong, Taiwan, Hungary, Ireland, Indonesia, Italy, Iran, Israel, Japan, South Korea, Latvia, Lithuania, Liechtenstein, Malta, Malaysia, Mexico, Netherlands, Norway, Poland, New Zealand, Kingdom United Kingdom, Portugal, Romania, Switzerland, Sweden, Turkey, Ukraine and the United States.

Along with Anvisa, the regulatory authorities of Armenia, Bulgaria and Italy (veterinary agency) are in the process of joining.

Top 10 destinations for Brazilian drug exports in 2018

* Considering the declarations made according to the NCMs informed by the exporters. Data extracted from the Comex Stat System of the Ministry of Economy. 

Original Publication: Anvisa