Thursday, April 5, 2012

Singapore - S'pore, M'sia drug agencies sign MOU to protect public health

SINGAPORE: The drug regulatory agencies of Singapore and Malaysia will work together to protect public health and safety after both sides signed a Memorandum of Understanding (MOU) in Singapore on Wednesday.

Under the agreement, Singapore's Health Sciences Authority (HSA) and Malaysia's National Pharmaceutical Control Bureau (NPCB) will ensure the safety, quality and efficacy of medicinal and health products manufactured, imported and exported between the two countries.

The agreement between HSA and Malaysia's Ministry of Health has been described as an important milestone.

HSA is the first national drug regulatory agency to sign an MOU with Malaysia's Ministry of Health.

The signing ceremony was presided over by Singapore's Health Minister Gan Kim Yong and his Malaysian counterpart Liow Tiong Lai.

It was signed by Chief Executive Officer of HSA, Associate Professor John Lim and Senior Director of the Pharmaceutical Services Division (PSD) of Malaysia's Ministry of Health, Ms Eisah A. Rahman.

The MOU aims to strengthen, promote and develop pharmaceutical regulatory affairs cooperation.

These cover areas such as regulatory science, enforcement, post market vigilance and Good Clinical Practice for clinical trials.

It'll be implemented through a Joint Committee.

Both sides will exchange of assessment reports in medicinal products registration and aim for work sharing to facilitate market entry of medicinal products.

They'll also share information on complementary health products and develop a system focusing on adverse signals for this particular class of products.

HSA will conduct joint audits with NPCB for confidence building and work to stamp out adulteration, as well as improve the quality of active pharmaceutical ingredients and finished dosage forms.

They'll build formal intelligence networks for effective sharing of information on counterfeits and adulterants so as to have more effective and increased enforcement actions.

The MOU formalises the strong ties between HSA and NPCB.

"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," said Assoc Prof Lim.

Ms Eisah said: "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 harmonise regulatory requirements that ultimately will benefit both our countries."

- CNA/fa

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