On 28 December 2018, the National Legislative Assembly (NLA) approved in principle the draft amendment of the Drug Act (Bill), as proposed by the Cabinet, and appointed an ad hoc committee to review the Bill. The Bill includes similar provisions to the Order of the National Council for Peace and Order No. 77/2559 from 2016 (which aimed to accelerate the approval process for all healthcare products).
The key proposed amendments which will affect operators include:
- Allowing experts (in the form of external organizations, government agencies, or private entities (both in Thailand and overseas)) that meet the required qualifications to enroll with the Food and Drug Administration Thailand (FDA) in order for such experts to evaluate academic documents, conduct product analyzes and audit business premises on behalf of the FDA. The aim of this is to facilitate and accelerate the drug approval process by lessening the workload on the FDA.
- An applicant for drug registration has to provide an information document about the relevant patent or petty patent or, in case of traditional drugs, the data regarding the registration of the right in Thai traditional medicinal wisdom.
- A drug registration license will be valid for five (5) years from the date of issue. Drug registration licenses that are issued before the Bill becomes effective will remain valid for five to nine years (depending on the year that such drug registration licenses were issued).
The NLA has placed this Bill on an urgent agenda and it is likely that the Bill could be passed soon. We will continue to monitor the progress of the Bill and provide updates on any further developments.
For further information, please do not hesitate to contact the Bangkok Healthcare team.