The Health Sciences Authority ("HSA") recently announced changes to the Guidance on Therapeutic Product Registration, which took effect as of 1 April 2018. These changes, which were subsequent to consultations with industry stakeholders, were aimed at improving processes to achieve greater transparency and predictability, as well as to lessen the regulatory burden on industry players.
Several of the significant changes are set out below:
- There will be a Turn-Around Time ("TAT") of 50 working days for the screening of new drug applications ("NDA"), generic drug applications ("GDA"), and major variation applications ("MAV") which are submitted in the Pharmaceutical Regulatory Information System ("PRISM"). The TAT will commence from the date on which the application dossier is received, and cease on the date of acceptance or non-acceptance, or withdrawal of the application. The TAT excludes the time which applicants take to address any input request from the HSA.
- The verification route for the submission of MIV-1 applications, will have a reduced TAT of 90 working days.
- For clarity to applicants, the HSA has amended the Application Checklists for NDA, GDA, and MAV to include details of documentation requirements.
- There is a new Dossier Clarification Supplement for NDA and GDA, which allows applicants to provide supplementary information and ascertain whether the quality aspects of a therapeutic product proposed in Singapore match those approved by the HSA's reference agencies (EMA, Health Canada, TGA, UK MHRA, US FDA). The approval must have been given within 5 years before the date of submission of the application to the HSA. This change allows the HSA to build on the assessment conducted by its reference agencies, and enhance the efficiency of the abridged evaluation route.
- Updates have been made to the guidelines on the registration of human plasma-derived therapeutic products, and the guidance on Drug Master File ("DMF"). These changes help to clarify the requirements for submission and reduce the need for the HSA to raise an Input Request / deficiency query because of the omission of information by applicants and holders of DMF / Plasma Master File.
- The precondition for comparative dissolution profile testing for GDA is subdivided in accordance with a risk-based approach. Requirements may be reduced for generic products in immediate-release solid oral dosage form which are to be registered as General Sale List medicine or Pharmacy-Only Medicine, provided they adhere to compendial standards.
- The precondition for bioequivalence data for GDA is now extended to Biopharmaceutics Classification System (BCS) Class III compounds.
More details can be found in the guidance documents on the HSA website here.