Address by the Regional Director at the 3rd Annual meeting of South-East Asia Regulatory Network (SEARN)

23-25 April 2019, New Delhi, India

Ms Preeti Sudan, Secretary, Health & Family Welfare, Government of India; Dr Reddy, Drugs Controller General of India; Michel Ward, Coordinator, Regulatory Systems Strengthening; partners, national and international; representatives of National Regulatory Authorities; members of the South-East Asia Regulatory Network; WHO colleagues from Geneva, the Regional Office and Country Offices, distinguished participants, ladies and gentlemen,

Welcome to the third Annual Meeting of the South-East Asia Regulatory Network.

This meeting provides a crucial opportunity to meet, take stock of progress and plan ahead. I thank and commend all National Regulatory Authorities for their enthusiasm.

The contributions you make will play a pivotal role in ensuring SEARN achieves its objectives and accelerates progress towards UHC – one of the Region’s Flagship Priorities, a core aim of WHO’s 13th General Programme of Work, and the key to reaching Sustainable Development Goal 3.

UHC dominates today’s global agenda.

WHO is committed to supporting SEARN enhance country cooperation, and in doing so, work towards sharing regulatory resources. These outcomes will be especially useful to the Region’s smaller countries due to the economies of scale they will have access to.

Distinguished participants,

The 2018 Delhi Declaration on Improving Access to Essential Medical Products, which ministers of each of the Region’s Member States endorsed, is unequivocal:

We will “continue momentum to strengthen regulatory cooperation and collaboration to improve the availability, quality and safety of essential medical products through the South-East Asia Regulatory Network”.

Let us take this opportunity to do precisely that, and build on the progress made at the second Annual Meeting in Colombo last year.

As you urged at that meeting, the Information Sharing Platform, or ISP, Gateway has now been developed by the Centre for Development of Advanced Computing.

At last year’s Regional Committee, ministers had an opportunity to see the ISP, which was operationalized the following month, in October.

The Gateway is progressively expanding the data it stores across several key regulatory areas.

As the ISP matures, I trust you will share alerts and confidential information to ensure quality medical products reach all people everywhere in our very large and diverse Region.

I urge all of you to make full use of the ISP Gateway to sustain and accelerate progress, and thereby maximize SEARN’s innovative potential.

That potential is well captured by SEARN’s five working groups, which support the overall objective of enabling communication and information sharing on regulatory policies, guidelines, standards, procedures, outputs and regulated products and entities.

The first working group is concerned with quality assurance and the development and enforcement of medical product standards.

I understand Working Group 1 has taken up mapping laboratory capacities as a priority. I am confident you will complete the task soon and overcome the non-availability of reference standards and impurities among some regulatory authorities.

The second working group focuses on building capacity on regulatory practices.

I urge Working Group 2 to fully leverage the strengths of regulatory authorities that already have robust Institutional Development Plans.

I am pleased to learn that you are considering a pilot collaboration on the approval of new antiretrovirals to treat HIV/AIDS and hepatitis, which could significantly expand access to affordable generic medicines produced in the Region.

The third working group’s focus can be summarized in a single word – vigilance.

To that end, Working Group 3’s efforts to develop policies, norms, standards and guidelines for vigilance at the country level will be crucial. I encourage you to ensure the negative experiences of any regulatory authority is rapidly exchanged with others to protect public health and safety Region-wide.

The fourth working group has helped shape the Information Sharing Platform, which has already been mentioned.

I am pleased that at last year’s meeting you added a fifth working group, pertaining to medical devices and diagnostics.

Working Group 5 is now building capacity in this area, keeping in mind country-specific needs and challenges, especially as they relate to diagnostics.

To support and encourage this area of work, WHO organized a one-day pharmacovigilance programme to be held directly after this meeting.

I thank the Andhra Pradesh Medical Technology Zone, Vishakhapatnam for their enthusiasm to host the event. I am sure Working Group 5 will make the most of the training.

Distinguished participants,

I understand you are actively engaged in developing a strategic plan that you will apply from the present year through to 2023.

In doing so, I trust you will establish clear deliverables that will enable us all to gauge progress and focus where focus is needed.

I cannot emphasize that point enough. The many partners gathered today are here to help, and I thank them for their presence. We all very much support this innovative initiative.

As many of you are aware, WHO’s triple billion targets are both bold and ambitious.

Your efforts to increase access to medical products are crucial to achieving them, and to staying on track to realize our own Flagship Priority and reach SDG 3 – to ensure healthy lives and promote health and well-being for all, at all ages.

With that in mind, I am inspired by your enthusiasm and encouraged by the momentum SEARN has already gained.

I am certain your collective wisdom and experience will contribute to the life-changing outcomes together we must achieve.

I wish you an engaging and productive meeting.

Thank you.