The Hong Kong government announced that starting November 1, a new streamlined process for drug approval will be implemented. This process aims to make it faster for medicines for serious diseases to enter the market in Hong Kong. Previously, for a new drug to be registered in Hong Kong, it required approval from two regulatory authorities worldwide. However, under the new “1+” mechanism, only approval from one reference regulatory authority will be needed.
This mechanism was initially introduced last November for new drugs treating life-threatening or severely debilitating diseases. Since then, five products have been approved through this process. The Department of Health stated that extending this relaxed regime to cover all new medicines will provide patients with more options and enhance the city’s ability to assess drugs effectively.
Alex Lam, the chairman of Hong Kong’s Patients’ Voices, expressed optimism about the benefits of this new regulation. He mentioned that Hongkongers can expect lower prices and a wider range of drugs in the market. However, he also raised concerns about the potential compromise in quality. Lam highlighted that with the previous requirement of approval from two high-standard regulatory authorities, the risk of lower quality drugs entering the market might increase with the new mechanism.
Lam emphasized the importance of ensuring patient safety, especially when drugs approved under this mechanism may come from countries with lower regulatory standards. He suggested that the government should play a crucial role in monitoring the outcomes of patients prescribed with these drugs, particularly in public hospitals. By closely monitoring the effects and any potential issues, the government can act as a gatekeeper to safeguard patient well-being.
In conclusion, while the updated drug approval guidelines aim to expedite the availability of medicines for serious diseases in Hong Kong, stakeholders like Alex Lam stress the importance of maintaining high-quality standards and prioritizing patient safety. It will be essential for the government to implement robust monitoring systems to assess the outcomes of drugs approved under the new mechanism and address any concerns promptly to ensure the well-being of patients in Hong Kong.