HK drug sector should raise GMP standards, report

The recommendation is one of 75 made by a joint committee of the Food and Health Bureau (FHB) and Department of Health (DoH) that was set up after a series of high profile contamination​ incidents last year.

The committee concluded that while all but one of Hong Kong’s licensed drugmakers​ comply with 1997 GMP standards, adoption of the current WHO guidelines, issued in 2007, would benefit both public safety and enhance the reputation of the industry.

It also advised that, once the 2007 standards have been fully adopted, regulators should begin work on upgrading the GMP requirements to meet those set out by the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

Food and Health Secretary York Chow, who presented the report earlier this week, agreed with the findings, commenting that the measures it recommends will “help raise the standards of the pharmaceutical industry and enhance the regulation of pharmaceutical products​.”

The move towards the adoption of more globally recognised GMP standards, and particularly those of the PIC/S, is also likely to benefit Hong Kong-based drugmakers seeking to expand outside the island's modest pharmaceutical market, which is worth around $975m (€679m) a year according to a September survey by Espicom.

Microbiological monitoring​

Within the GMP recommendations, the review paid special attention to microbiological monitoring procedures for non-sterile drugs in light of deaths linked to the fungal contamination of drugs made at Europharm laboratories HK plant​.

The committee said that, in addition to carrying out a greater number of microbiological analyses during manufacture, drugmakers should limit the time that granulated drug components are stored to no more than 48 hours.

Other recommendations include that a licensing system for those responsible for signing off on drug batches, known as authorised persons (AP) in Hong Kong and qualified persons (QP) elsewhere, is developed and maintained and that APs are required to have a greater deal of industry experience.

The report, which is due to be discussed at a meeting of Hong Kong’s Legislative Council on Health Services on Monday, is available here​.