Hong Kong patients could have quicker access to new drugs if authorities streamline certification process, experts say
- Approval process is slowed down by current requirements, say experts calling for a change of rules
- Safety of newly approved drugs can be ensured by asking drug companies to provide local clinical data
Hong Kong patients could have quicker access to new drugs if authorities ease the city’s approval process by asking pharmaceutical companies for only one registration certificate instead of two or more, experts have said.
Secretary for Health Lo Chung-mau in June said the city needed a faster drug approval process to become a regional biomedical innovation hub, and revealed that authorities were considering setting up a primary evaluation agency similar to the United States Food and Drug Administration.
The Post learned that the government was “brainstorming” whether to halve the number of approvals required for a new drug.
Professor Ian Wong Chi-Kei, head of the University of Hong Kong’s department of pharmacology and pharmacy, said the current approval process was slow since drug companies had to submit two or more registration certificates for new products.
“Patients can receive new drugs faster if the required number of certificates is cut from two to one,” he said. “Most of the new drugs nowadays are immunotherapy medicines for treating cancer. With a fast drug approval process, patients can receive better treatments sooner.”
Wong is also a member of the government’s Pharmacy and Poisons Board, which oversees the registration and classification of pharmaceutical products.
To ensure the safety of new drugs, he suggested that authorities ask drug companies for local clinical data after giving initial approval based on only one registration certificate.
