Reported by Lu Xuei-Hui from Taipei

The Executive Yuan yesterday passed the “Draft Regulations Governing the Establishment of the National Center for Drug Evaluation”, which provides the legal basis for a national agency for drug review.  The Center is aimed to streamline the drug review process so as to reduce the lead time for the launch of new drugs.  The Center will also provide guidance and consultation services concerning new drug R&D with a view to promoting Taiwan as a key player in global biotech R&D industry. 

The existing Center for Drug Evaluation (CDE) was established by the Department of Health (now the Ministry of Health and Welfare, MOHW) in 1998.  Since then, it has been in charge of the review of the technical dossiers for new drug applications and clinical trials.  However, foreign drug companies have been complaining to the Taiwanese government that the drug review process is too time-consuming.  They urge the government to follow international practices and streamline the regulatory procedure for licensing new drugs.  Furthermore, the CDE is currently funded by the government’s budget, putting an uncertainty on the CDE’s finance. 

The “Draft Regulations Governing the Establishment of the National Cener for Drug Evaluation” passed by the Executive Yuan, along with the amendment of the Pharmaceutical Affairs Law, will lay the foundations for the establishment of a national drug review agency, said Ho Chi-Kung, Deputy Minister of the MOHW.

The drug review process will be streamlined from 3 stages to 2 stages.  At Stage 1, the Center will review the technical dossiers; and, at stage 2, the TFDA will issue drug or medical device licenses based on the consideration of public health or ethics.

Ho Chi-Kung expressed that it will be quite an achievement if the review process can be shortened by 1-2 month.  The Center has another function which is to provide clinical and non-clinical guidance for drug developers in Taiwan to save them from wasting their time and efforts.

Both foreign and local drug companies have been complaining about poor review efficiency.  On average, half of NCE new drug applications take 360 days to complete the review; and 41% of the generic applications take 180 days to complete the review.  The review time varies from case to case. The Center is expected to increase the percentage of the 360-day review deadline for NCE new drug applications form 50% to 90%, and to increase the percentage of the 180-day review deadline for generic applications from 41% to 90%.

【2017-02-03/ Commercial Times】