Since November 2023, the Department of Health has made it easier for new drugs to be registered.
Called the “1+” mechanism, pharmaceutical products would only need a single registration issued by an existing reference drug regulatory authority, down from two.
Initially open to drugs used to treat life-threatening or severely debilitating diseases, the rule was further extended last year to all new drugs.
Eleven new drugs have so far been registered under the regime, five of which have already been added to the Hospital Authority’s formulary.
The department added that as of mid-March, it has received 400 enquiries from more than 110 pharmaceutical companies on drug registration matters.
To better help the industry understand the regulatory requirements, it will launch a consultation service starting with an online briefing seminar next Monday.
Assistant Director of Health Frank Chan noted that some overseas or mainland firms are not familiar with the new rules.
“They are not quite sure or quite understand our registration requirements,” he said.
“Once they got the information, they may discuss with their company to see whether they want to go ahead with the applications… so that we [don’t have] to go back and forth to ask them to provide the supplementary information.
“That will enhance our efficiency for the approval of the application,” Chan said.
He added the department is planning to hold workshops in June and meet potential applicants face to face later in the year to further expedite the process.
