Smaller regulators grasp innovation through international collaboration

2024-04-23

基因疗法

Smaller regulators grasp innovation through international collaboration

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来源: Pharmaceutical Technology

Caption: Experts recommend collaboration between regulatory agencies to increase market access to essential medicines. Credit: Vitalii Stock via Shutterstock

Smaller regulatory agencies could introduce more therapies into their national markets through faster regulatory processes, said Dr. Ulf Grawunder, managing partner at Viopas Venture Consulting, at the Swiss Biotech Day conference.

At the Swiss Biotech Day conference, which concluded today, experts gathered to discuss the potential for regulators to push innovation in their respective regions. During a panel with regulators from different countries, Grawunder said agencies like Switzerland’s Swissmedic (the Swiss Agency for Therapeutic Products) and Brazil’s Anvisa (National Health Surveillance Agency), could compete with larger regulators such as the US Food and Drug Administration (FDA) to attract more innovative medicines.

In 2024, the FDA approved 71 new medicines, compared to Swissmedic’s 41 marketing authorisations. In May 23, The FDA reported that its office of regulatory affairs had 227 offices and 12 laboratories globally.

“Agencies around the world tend to connect with each other, but they’re also in competition,” said Dr. Philippe Girard, the head of medicinal product licences and surveillance at Swissmedic. “We have to be as fast as reasonably possible but whilst maintaining the quality of approved therapies,” said Girard. He added that smaller regulators pulled ahead in the US in the evaluation and approval timelines for certain types of therapies such as cell and gene therapies. For example, in December 2023, Swissmedic approved Orchard Therapeutics’ haematopoietic stem cell (HSC) gene therapy, Lenmeldy (atidarsagene autotemcel), also known as Libmeldy. The FDA followed this with an approval in April 2024.

Girard said that for smaller regulators, partnerships and collaborations with other national agencies could be a key method for ensuring quicker access to essential therapies. Swissmedic is part of the Access Consortium alongside the Australian Therapeutic Goods Administration (TGA), the Health Products and Food Branch (HPFB) of Health Canada, Singapore’s Health Sciences Authorities and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The consortium comprises several working groups that investigate work-sharing initiatives between the different countries. The consortium aims to reduce duplication in the evaluation process to ensure access to medicines, as per the group’s 2021-2024 strategic plan.