HSA Signs Memorandum of Understanding with the Ministry of Health, Malaysia

Singapore's Health Sciences Authority (HSA) today signed a Memorandum of Understanding (MOU) with the Ministry of Health (MOH) of Malaysia. This is an important milestone for both parties as HSA is the first National Drug Regulatory Agency the Ministry of Health, Malaysia is signing an MOU with.

2      The MOU signing ceremony was presided over by Mr Gan Kim Yong, Singapore's Minister for Health, and Dato' Sri Liow Tiong Lai, Malaysia's Minister for Health, who witnessed the signing between Associate Professor John Lim, Chief Executive Officer of HSA and Dato' Eisah A. Rahman, Senior Director of the Pharmaceutical Services Division (PSD), Ministry of Health, Malaysia which was held at The Fullerton Hotel Singapore.

3      As National Drug Regulatory Agencies, both the HSA and the National Pharmaceutical Control Bureau (NPCB) of the MOH, Malaysia protect public health and safety of their respective nations by ensuring the safety, quality and efficacy of medicinal and health products manufactured in, imported and exported from Singapore and Malaysia.

4      This MOU formalises the strong ties already established with HSA and NPCB through the ASEAN Pharmaceutical Product Working Group where there has been strong cooperation between the health regulatory agencies in various work groups, including the Mutual Recognition Agreement (MRA) on Good Manufacturing Practice (GMP). HSA and NPCB also work closely in the ASEAN Traditional Medicines and Health Supplements work group chaired by Singapore with Malaysia as Vice-Chair, and which is working towards a harmonised regulatory framework in ASEAN. In addition, both co-lead the ASEAN Post Market Alert System where members alert each other on adverse signals.

5      The newly inked MOU seeks to strengthen, promote and develop pharmaceutical regulatory affairs cooperation in areas that include regulatory science, enforcement, post market vigilance, GMP and Good Clinical Practice (GCP) for Clinical Trials. The MOU will be implemented through a Joint Committee jointly chaired by Associate Professor John Lim, Chief Executive Officer of HSA and Dato' Eisah A. Rahman, Senior Director of PSD.

6      The areas of co-operation will include the following:

(1)Exchange of assessment reports in the area of medicinal products registration and work towards future work sharing which would facilitate market entry of medicinal products in both nations
(2)Sharing of information on Complementary Health Products and developing a system focussing on adverse signals for this particular class of products
(3)Joint audits with NPCB for confidence building and/or work sharing in an effort to stamp out adulteration and to improve the quality of active pharmaceutical ingredients, as well as finished dosage forms
(4)Build up of formal intelligence networks for effective sharing of information on counterfeits and adulterants so as to have more effective and increased enforcement actions bilaterally

7      Said Associate Professor John Lim, “This is a very significant MOU for HSA. We have had a strong professional and collegial working partnership with NPCB for many years and I am delighted to further consolidate this through signing our MOU. This establishes a common platform for open sharing of regulatory updates and regular dialogues between our two agencies. Prompt information exchange ensures that we are current about each other's regulatory issues and challenges, and allows us to work closely to be even more responsive and ready to promote public health and safety effectively within our region. We look forward to a fruitful, mutually beneficial partnership that will not only open up exciting areas for cooperation in regulatory science and systems, but will also deepen the good relations between our agencies.”

8      “The signing of this MOU marks a new chapter for NPCB and HSA as we hope to further strengthen our bilateral technical cooperation in the area of pharmaceutical regulatory control. Indeed, the NPCB is extremely delighted that this MOU is finally signed after long years of friendship and close partnership particularly in the area of pharmaceuticals. It certainly reflects the strong commitment of both agencies to share and exchange relevant information with regard to ensuring quality, safe and efficacious products to protect consumers and promote public health. While we have many things in common, let us hope that such close collaboration will steer us forward in our efforts to facilitate processes and harmonize regulatory requirements that ultimately will benefit both our countries,” said Dato' Eisah A Rahman.

HEALTH SCIENCES AUTHORITY
28 MARCH 2012

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