Representatives of national health regulatory authorities from around the world convened in Moscow to discuss ways to harmonize regulatory standards for biotherapeutic medicines.
The conference, Biotherapeutic medicines: regulatory challenges and current practices - approaches for harmonization, was the first international expert meeting of its kind to take place in Russia. Participating in the conference were experts from Russia, Belarus, Kazakhstan, Ukraine, the World Health Organization, Health Canada, several European national regulatory agencies, and industry. Participants were scheduled to discuss current challenges in regulating biotherapeutic and biosimilar medicines and exchange best practices.
The conference was organized by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in cooperation with the Association of International Pharmaceutical Manufacturers (AIPM). It is held with the support and participation of the Ministry of Health of the Russian Federation, the Russian Federal Service for Healthcare Supervision, the Eurasian Economic Commission, the State Duma Committee on Health Protection, and the Russian Academy of Medical Sciences.
Ahead of the conference, AIPM Executive Director Vladimir Shipkov said in a statement, "Due to the complex nature of biotherapeutic medicines, harmonized regulatory standards are needed to best serve the interests of patients and healthcare systems throughout our region. I hope this conference will contribute to the establishment of a regulatory system for biotherapeutic and biosimilar medicines in Russia based on global best practices and established regulatory procedures.”
IFPMA Director General Eduardo Pisani said, "Biotherapeutic medicines open new possibilities for medicines and offer cures for some diseases that were previously considered untreatable. With more than 200 biotherapeutic medicines now registered and many others in the pipeline, science-based, harmonized regulatory approaches are needed. This conference is an important platform for sharing regulatory best practices among leading Russian and international experts."