Updated on 1 October 2012
We also address public safety concerns about counterfeit and unregistered drugs, sharing the international experience of manufacturing quality drugs, knowledge of good manufacturing practices (GMP) and pharmacovigilance reporting system. We also provide education to patients on healthcare and treatment options by partnering with healthcare professionals, such as doctors and pharmacists. The association has actively participated in events of the health community and presented its views to the public on different health issues such as healthcare financing, drug policy and undesirable medical advertisements ordinance amendment bill.
What are the challenges of registering a pharmaceutical product in Hong Kong?
There is not very much clarity in classification of pharmaceuticals and its definition in the law book of Hong Kong and in its dosage form and format of the product, whether it is substance or mixture of substances. For example, in vitamins and minerals some vitamins have to be registered as drugs, including vitamins A, D, E, H and K that exceed in dosage, vitamins B1, 2, 3 that are greater than 0.2 mg. In many countries of the world a special category for nutritional product may not require certificates for registering these product as pharmaceuticals.
What steps can be taken by the authority and the industry to have a better registration process?
According to the industry views, organization responsible for drug approval can overcome the challenges by creating a dedicated team for different aspects of pharmaceutical regulations. The industry has to adopt a sophisticated system instead of a simple one. There needs to be a team to specialize on pharmacovigilance and a dedicated qualified person should be appointed in Hong Kong office.
Hong Kong can also migrate to computerized system for drug registration, for import and export licensing system and allow E-submission. Besides, more concern on safety and quality and more reference documents should be required. The country needs much sufficient manpower and to take lot of new initiatives. The industry has to adopt the changes, get access to clear communications with authority and provide better training to the team to serve the initiatives.