Singapore and Japan Deepen Collaboration Through Reliance Mechanisms to Enhance Access to Health Products

Singapore's Health Sciences Authority (HSA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) signed a Memorandum of Cooperation (MOC) on 20 April 2026 in Tokyo, Japan, 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.

2       The MOC, signed by Adjunct Professor (Dr) Raymond Chua, Chief Executive Officer of HSA, and Mr Naoki Miyamoto, Director-General of the Pharmaceutical Safety Bureau of MHLW, 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.

3       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.

4       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.

5       This agreement is a result of years of collaboration since the signing of the Japan – Singapore Economic Partnership Agreement (JSEPA) in 2002 between the two governments, followed by a signing of the 2010 Memorandum on Information Exchange between HSA, MHLW and Japan's Pharmaceutical and Medical Devices Agency (PMDA), which aimed to strengthen and broaden information regulatory information exchange bilaterally. The agreement will also strengthen HSA’s plans to grow and develop the biomedical industry, a key contributor to Singapore’s economy. 

6       Adjunct Professor (Dr) Raymond Chua, Chief Executive Officer of HSA, said: “We value our strong partnership with MHLW and PMDA, that has been growing from strength to strength since 2010. As we collaborate through this MOC, we will further strengthen our collaboration in mutual reliance in Good Manufacturing Practice inspections of pharmaceutical manufacturers. And by continuing to share knowledge and expertise, we aim to enhance efficiency, promote safety standards, and enable greater access to high-quality medicines in both countries and across Asia.” 

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