Singapore and Japan deepen collaboration to enhance access to health products

Singapore's Health Sciences Authority (HSA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) have signed a Memorandum of Cooperation (MoC) to enhance bilateral cooperation in health products regulation.

This MoC marks a significant milestone in strengthening the partnership between the two government entities and reinforces the shared commitment to advancing regulatory excellence through international collaboration to benefit pharmaceutical manufacturers and ultimately, patients who need medicines.

The MoC seeks to promote cooperation in key areas of mutual interest, including collaboration in facilitating reliance for health products, Good Manufacturing Practice (GMP) inspection reliance of pharmaceutical manufacturers, information exchange on cutting-edge technology, and partnerships in international and regional programmes and scientific initiatives.

A key focus of the MOC is to establish GMP inspection reliance arrangements that could enable mutual reliance of GMP certificates and inspection outcomes for pharmaceutical manufacturers in both countries. This will streamline regulatory processes, for example by removing duplicative inspections for manufacturers, which in turn may help patients in both countries get access to safe medicines faster and more easily. This is expected to remove an average of three duplicative inspections per year and improve access of medicines by up to six months.  Even as processes are streamlined, they will continue to adhere to strict safety standards.

The MoC also gives both entities a formal mechanism to collaborate across different stages of the product lifecycle – from clinical trials review, product reviews, registration and reliance, manufacturing through to post-market oversight – to strengthen regulatory reliance and support innovation for products such as medicines, cell, tissue and gene therapy products and medical devices...