Handling of Applications and Conduct of Inspections During COVID-19

Provides update on how dealer’s licence and certificate applications will be handled and how inspection will be conducted during COVID-19

Handling of Applications and Conduct of Inspections During COVID-19

The COVID-19 pandemic has triggered national and international restrictions that have affected the conduct of on-site, face-to-face GMP and other regulatory inspections.

HSA remains committed to maintain an effective monitoring programme for  licensed manufacturers and dealers, and to ensure availability of GMP certificates to support regulatory submissions. To avoid disruptions in the supply of medicines, the HSA has adopted a risk-based approach to enable continued regulatory oversight and the assessment of manufacturers and dealers during this period of time.

As the Circuit Breaker measures have been lifted from 2 June and we transition to Phase 1 and Phase 2 to reopen the economy, the HSA inspectors will assess the various means available for inspection in consultation with each specific manufacturing site. This may range from a fully virtual inspection, a hybrid of virtual and on-site inspection to a fully on-site inspection where it is deem as necessary and safe to undertake. 

If an on-site inspection is required, all necessary measures will be taken to mitigate the risk of transmission of infection and the potential impact of the on-site inspection to the health and safety of company’s personnel and the inspectors involved.

For a virtual inspection to be feasible, we recommend that the company has a reliable wifi network in place, a stable internet connection, up-to-date remote video communication system, a mobile device enabled with video streaming function and connectivity to the internet (for virtual live tour), document scanner and document exchange platform, where possible.

If a virtual inspection is carried out, the pre-inspection process, inspection proceeding and post-inspection process are largely similar to an on-site inspection except that the on-site interaction between the inspectors and the company would be based on teleconferencing and video conferencing.

Assessment of Overseas Manufacturers

Due to on-going travel and border control restrictions, and risk considerations on the health and safety of our inspectors, the HSA will put the applications for all overseas inspections on hold until it is feasible for overseas travel to resume for on-site inspection of a manufacturing site in a foreign country.  

We will continue to review our risk-based approach for the assessment of all licence or certificate applications and make the appropriate adjustment as the situation develops.

Share