Opening remarks of Dr Shin Young-soo, WHO Western Pacific Regional Director at the Seventh Workshop for National Regulatory Authorities for Medical Products in the Western Pacific Region

Distinguished colleagues from regulatory agencies
Partners and donors
Ladies and gentlemen

I am very pleased to welcome you to Manila for the Seventh Workshop of the Regional Alliance of National Regulatory Authorities in the Western Pacific Region.

I would like to thank all of you for your commitment to strengthening regulation of medical products over the last seven years. Having strong medical product regulators is crucially important to improving the health of people in our Region.

Over the past few months, there have been several incidents where the quality and safety of medical products has been called into question: the recall of rabies vaccine and a cardiovascular drug in China, and the suspension of MMR vaccine in Samoa.

While the context for each of these events was very different, they all demonstrate the importance of having strong regulation, and effective regulators. Each of these incidents was clearly regrettable. However, I have been pleased at least to see that in each case, the national regulatory authority played a key role in identifying and responding to the problems that were identified.

I have also been impressed by the collaboration amongst this network that has been on display in addressing these and other events. You have shown how good coordination amongst regulators helps to ensure timely action to address public health emergencies in which concerns over patient safety of medical products play a part – especially those with potential ramifications for other countries.

We need both strong regulators in each country, and a strong network of regulators across the Region. We have taken huge strides towards achieving this over the last seven years, but we are not there yet.

Just as there are inequities in access to medicines and some vaccines between countries, the level of regulatory capacity varies between Member States. We must focus on closing the gaps in regulatory capacity so that we ensure safe and good quality medical products for everyone – this is a key component of universal health coverage.

In medicines regulation, inequities happen when resources and capacities are inadequate, or when the regulatory system itself is insufficiently robust. This results in regulators being slow, or unable, to take the kinds of timely and effective action which is necessary to protect public health.

Of course, the regulatory system in any country reflects its national health policies, priorities and needs. However, we should strive to apply best practices for regulations in every country, adapted to national contexts, in order to achieve the best possible regulatory outcomes for every country.

With this goal in mind, in 2017 the Regional Committee for the Western Pacific endorsed the regional Action Agenda on Regulatory Strengthening, Convergence and Cooperation for Medicines and the Health Workforce.

Many of you here today helped contribute to the development of this document – we thank you very much for your efforts and contribution.

The Action Agenda provides guidance to Members States on cooperation and convergence to strengthen regulatory systems – in order to ensure the safety, effectiveness and quality of medicines and vaccines. It also provides a framework for sharing experiences across countries, and building upon the best regulatory practices.

Regulatory convergence and cooperation are desirable at both national and international levels. Our goal is for every Member State to have the capacity to take necessary, timely and effective action to ensure safety and quality of medical products and protect public health.

For countries with fewer resources or where there are weak or no regulations in place, this could mean tapping into the capacities of more advanced regulatory authorities, at least in the first instance. Supporting these kinds of exchanges, especially for Pacific Island countries, will be WHO’s focus over the next few years.

Ultimately, our mission is to make this region healthier, more secure and reach universal health coverage. To achieve this, there are a number of areas where the role of national regulatory authorities is critical: First, ensuring the availability of quality assured and safe vaccines and medicines. This is obviously crucial for accelerating the eradication and elimination of high risk infectious diseases;

Second, ensuring the timely availability of vaccines and medicines in public health emergencies;

Third, eliminating and preventing the entry of falsified and substandard medicines into the market;

Fourth, strengthening pharmacovigilance and monitoring systems for adverse events, to improve patient safety and quality of care at all levels;

Fifth, ensuring quality and safety of antimicrobials, and regulating their distribution and use – to help prevent antimicrobial resistance;

And finally, developing appropriate regulatory strategies to support countries to ensure quality and safety of traditional medicines. Traditional medicine continues to be an important part of the health care delivery system in many countries and should be regulated accordingly.

While we have come a long way over the last seven years, but we still have a lot of work to do. But I am confident that with the continued commitment and support of this alliance, regulators in this region will continue to be at the forefront of improving and securing the health of the people in this Region.

Thank you again for being here, and I wish you a productive and successful meeting.

Thank you.

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