Hong Kong clarifies GMP requirements for Active Pharmaceutical Ingredients

Hong Kong’s Drug Office from the Department of Health has recently announced that as a registration requirement, active pharmaceutical ingredients (“APIs”) must comply with the applicable Good Manufacturing Practice (GMP) requirements.

What This Means for Pharmaceutical Companies

Applicants must provide appropriate evidence that the relevant API manufacturers comply with applicable PIC/S GMP standards as part of pharmaceutical product registration.

Preparing for Registration

The key takeaway is that API GMP compliance is an integral part of Hong Kong’s pharmaceutical registration requirements. Companies should ensure that their supporting documentation adequately demonstrates compliance with the applicable requirements.

Elidex Pharma supports Hong Kong market-entry preparation through regulatory gap assessments, GMP documentation reviews and coordination with manufacturers and local registration partners.