The regulators should focus on convergence to push innovation, accessibility and affordability of medicines for all, said the pharma regulators from 50 countries who participated in the three-day iPHEX-Global Regulators Conclave organized by the Pharmaceuticals Export Promotion Council (Pharmexcil) in association with the Ministry of Commerce and CDSCO. The conclave concluded here on Friday.
V G Somani, Drug Controller General of India (DCGI), said the industry, too, has a “great role to play in matching regulatory expectations of different nations.”
The process of regulatory convergence was adopted to some extent during the pandemic, said R Uday Bhaskar, DG, Pharmexcil, adding that the same agenda should be continued.
According to Mojisola Christianah Adeyeye, DG-NAFDAC, Nigeria regulatory convergence had already begun during the Covid-19 pandemic for accessibility of vaccines.
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“We need to have new regulatory practices and reliable processes and one of the ways to do it is collaborative registrations,” she said.
Vladislav Shestakov, Director, State Institute of Drugs and Good Practices, Russia, said while convergence was the need of the hour, it’s a multi stage process and a supranational regulatory network had to be created.
Russia was taking an initiative to create a new global association for pharma inspectors and ready to work with other countries, including India, Shestakov added.
For Kang Seogyoun, DG-MFDS, South Korea, there were challenges in the drug supply. Harmonisation of regulation could provide solutions.
Matias Bela Szentivanyi, DG, National Institute of Pharmacy and Nutrition, Hungary, said that there was a need to go beyond regulatory sphere. “Drug approvals and finances should come together. Enhance international regulatory capacity and supply chain capability,” he added.
Olga Lidia Jacobo Casanueva, DG-CECMED, Cuba, suggested the process of regulatory convergence can gradually begin with acceptance of technical guidance documents, exchange of scientific and technological details and bilateral regulatory pacts.