The Health Sciences Authority (HSA) of Singapore has been internationally accepted as a Regulatory Member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

This marks a significant milestone for HSA as it joins the ranks of big regulators, including the US Food and Drug Administration.

HSA’s membership was announced at the recent meeting held in Geneva in November 2017.

As a Regulatory Member of ICH, HSA has earned international recognition as a country with an advanced regulatory system for pharmaceutical products.

HSA will have first rights, together with other ICH members, to participate in ICH expert working groups, and to vote on all matters raised at ICH meetings.

This assures that Singapore’s views are represented when developing the various ICH guidelines relevant to Singapore, for example the guidelines determining product registration, manufacturing and safety monitoring.

HSA’s membership will also facilitate the entry of local pharmaceutical and biotechnology industries into other markets.

It will also be easier for a company to launch a new drug in many countries at the same time if regulatory requirements for drugs are aligned, enabling faster global access to a new drug. 

Regulators and industry associations from the United States, Europe and Japan established the ICH in 1990, with the mission of achieving greater harmonisation worldwide to ensure that safe, effective and high quality medicines are developed and registered in the most resource-efficient manner.

Singapore first joined the ICH in 2008 with HSA as an observer. It is now the ninth Regulatory Member, after Canada, Switzerland, the Republic of Korea, China and Brazil.