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Singapore Japan Health Products Reliance MOC Signed

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Summary

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 to enhance bilateral cooperation in health products regulation. The agreement establishes GMP inspection reliance arrangements enabling mutual recognition of GMP certificates and inspection outcomes for pharmaceutical manufacturers, potentially removing an average of three duplicative inspections per year and improving patient access to medicines by up to six months. The MOC covers the full product lifecycle from clinical trials through post-market oversight, building on prior cooperation since the 2002 Japan–Singapore Economic Partnership Agreement.

“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.”

HSA , verbatim from source
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What changed

The MOC establishes a formal framework for regulatory reliance between Singapore and Japan in health products regulation. Key provisions include mutual reliance of GMP certificates and inspection outcomes, information exchange on cutting-edge health technologies, and collaboration across the product lifecycle from clinical trials through post-market oversight.

Pharmaceutical manufacturers in both countries may benefit from streamlined regulatory processes, potentially gaining faster market access through reduced duplicative inspections. The agreement covers medicines, cell, tissue and gene therapy products, and medical devices, providing manufacturers with greater certainty on compliance pathways in both jurisdictions.

Archived snapshot

Apr 22, 2026

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

Health Sciences Authority and Japan’s Ministry of Health, Labour and Welfare sign Memorandum of Cooperation in areas such as reliance in health products, and information exchange on latest health technologies

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.”

7       “HSA has been an invaluable partner to work together in the area of regulatory harmonisation. As an opportunity to conclude MOC this time, I expect that MHLW and HSA will deepen regulatory cooperation toward mutual goals of both countries,” Mr Naoki Miyamoto, Director-General of the Pharmaceutical Safety Bureau, MHLW, stated.
HEALTH SCIENCES AUTHORITY SINGAPORE 21 APRIL 2026
ANNEX

From left:

  • Dr Yasuhiro Fujiwara, Chief Executive, Pharmaceuticals and Medical Devices Agency, Japan.
  • Adjunct Professor (Dr) Raymond Chua, Chief Executive Officer, Health Sciences Authority, Singapore.
  • Mr Naoki Miyamoto, Director-General of the Pharmaceutical Safety Bureau of Ministry of Health, Labour and Welfare, Japan.
  • Dr Daisaku Sato, Assistant Minister for Technical Affairs (Pharmaceuticals), Ministry of Health, Labour and Welfare, Japan.

Photo credit: Ministry of Health, Labour and Welfare, Japan.

Consumer, Healthcare professional, Industry member Published:

21 Apr 2026

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21 Apr 2026

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Last updated

Classification

Agency
HSA
Published
April 21st, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Pharmaceutical companies Healthcare providers Patients
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Regulatory cooperation GMP inspection reliance Product lifecycle collaboration
Geographic scope
Singapore SG

Taxonomy

Primary area
Healthcare
Operational domain
Regulatory Affairs
Topics
Pharmaceuticals Medical Devices International Trade

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