PAHO moves forward with the study of a regional regulatory framework to harmonize pharmaceutical products
10 diciembre 2021


The X Pan American Conference for the Harmonization of Pharmaceutical Regulation, sponsored by PAHO, was held between December 6 and 10. The conference was attended by members of the national regulatory agencies of the Americas, academics, NGOs and pharmaceutical companies. At the end of the meeting, PAHO undersecretary Jarbas Barbosa announced the intention to create a regulatory policy at the Pan-American level to guarantee the quality of antimicrobial, generic and biosimilar drugs to be regulated by national health authorities under the best international practices.

 During the conference, Analía Porrás, head of PAHO’s Medicines and Health Technologies Unit, highlighted the progress made in the last decade in terms of regulatory harmonization among the countries of the Americas. She highlighted the work of the regional reference regulatory authorities and the agreements signed between them and other regulatory agencies with the aim of cooperating in the transfer of information as well as in the homologation of regional regulatory standards. A highlight was the work done in the Caribbean with the Caribbean regulatory system, where the CARICOM countries worked on the joint acceptance of 210 products recommended by their regulatory reference authorities.

 However, throughout the conference, the weaknesses of the American regulatory system were detected: although 82% of the population lives under the regulations of the reference authorities, only 23% of the countries in the region have reference authorities. Porrás also stressed that the region must strengthen the harmonization of regulations under international standards, as this will allow products with components produced in different parts of the world to have the same quality in production.

 In turn, Barbosa pointed out that although the region has made significant progress in strengthening the regulatory system, the steps to be taken in the coming months are to reinforce the weak points of the American regulatory system: market surveillance and after-sales service. With market surveillance, PAHO hopes to reduce the presence of counterfeit drugs in the region. With after-sales service, it is hoped that drugs will reduce their adverse effects and that production will be more efficient in the future.

 Likewise, in terms of regulatory harmonization, Barbosa emphasized that regulatory agencies must have technical independence, perform risk management and have independent accountabilities to guarantee the work carried out by these entities. He also pointed out that the pharmaceutical industry must be transparent in terms of the products manufactured, in order to ensure that a drug produced in one country or region is of the same quality as another produced in the Americas.

 In order to guarantee the independence of the regional authorities, while maintaining cooperation among them, with a view to ensuring the best international practices in the control of global value chains, Barbosa announced that in 2022, a regulatory policy will be adopted at the regional level to be adopted at the next Pan-American sanitary conference by the member countries.