Keynote Address by the

Director General of Health Malaysia

National Regulatory Conference 2015

‘Transformation towards a New Regulatory Paradigm’

One World Hotel, Petaling Jaya

Tuesday, 4 August 2015

(9.45 – 10.15 am)

i) Yang Berbahagia Dato’ Eisah A. Rahman

Senior Director of Pharmaceutical Services, Ministry of Health

ii) Yang Berusaha Mr Tan Ann Ling

Director of National Pharmaceutical Control Bureau and Chairman of the NRC 2015 Organising Committee

Distinguished speakers, directors and representatives of government agencies, presidents of industry associations, speakers, participants, ladies and gentlemen:

Good morning and Salam Sihat 1 Malaysia.

I have the great pleasure to present the keynote address to the National Regulatory Conference 2015 (NRC 2015), organised by the National Pharmaceutical Control Bureau (NPCB) in collaboration with the Malaysian Pharmaceutical Society (MPS). I was informed that this has been an eagerly anticipated function and previous NRCs were often oversubscribed.

Distinguished guests, ladies and gentlemen,

We are entering an era of pertinent transformations in the global healthcare delivery system. More so now than ever before has the healthcare system been challenged to deliver amidst increasing expectations in health-related aspects including key operational, clinical and governance functions, all while juggling the pressure of rising costs and decreasing public tolerance to inefficiencies.

In times of health urgency, the drug regulatory system often deals with conflicting demands from its stakeholders. Patients demand prompt and affordable yet safe access to a life-saving treatment. The drug industry expects efficient regulatory approval balanced against limited clinical data in the assessment of a groundbreaking treatment for early market capture. At the same time, regulators are tasked to enforce stringent checks on products prior to market release in keeping with the universal health mandate to protect the patient’s safety while ensuring prompt access to effective medicines. As drug regulators frequently endure these regulatory conundrums, a clear solution calls for a “Transformation towards a new regulatory paradigm”. This, ladies and gentlemen, is the theme of NRC 2015.

The Drug Control Authority (DCA) is an executive body for the approval of pharmaceutical and health products in Malaysia. Since its establishment in 1984, the DCA and its secretariat the National Pharmaceutical Control Bureau (NPCB) have matured considerably. The past 30 years have witnessed an expansion of the regulatory control framework across all product categories: from its early days in control of prescription and over-the-counter medicines, through to the control of traditional medicines, cosmetics and veterinary medicines, and finally taking on the challenge to control new chemical entities, active pharmaceutical ingredients and biologics. I must say it has been a long and arduous journey for our regulators to establish sufficient control on a diverse portfolio of healthcare products, while working on enhancing organisational capacity. At NPCB, major milestones along the way of its expansion to the organisation it is today include its appointment as a WHO Collaborating Centre in the Regulatory Control of Pharmaceuticals since 1996 and its accession as a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) since 2002.

Notwithstanding our past achievements, I must admit that our drug regulatory agency has much catching up to do with established agencies such as the US FDA or the European Medicines Agency (EMA). If we envision standing as an equal among our international colleagues, then we have to move in stride with them to employ new technology and tools in achieving the best current regulatory practices. This is especially true in consideration of advances in the fields of regenerative medicine. As I am speaking to you, the Ministry of Health is concentrating efforts among its divisions to establish a regulatory framework and control on manufacture and administration of cell and gene therapy products (CGTPs) in our health institutions, of which the update will be presented during this conference. What is clear, our work process and technical capacity must be strengthened to meet new healthcare challenges.

Today, a common challenge among all regulatory agencies, big or small is to ensure timely and equitable access to medicines.

In ensuring timely access to medicines, even established regulatory agencies are not spared from calls for flexible drug authorisation models in order to reduce the time-to-market of innovative and life-saving medications. Regulatory capacity is perpetually scrutinised in order to establish new strategies to shorten marketing authorisation timelines. In the European Union, talks have begun among stakeholders to establish Medicine Adaptive Pathways to Patients (MAPPs) for new and innovative medicinal products. In the US FDA, the availability of a breakthrough designation accords promising new products a shorter time to market introduction. These and many more innovative regulatory paths will continue to dominate the international regulatory scene for years to come.

The current debate on transforming the drug regulatory pathway worldwide invites our Malaysian regulators and industry players to engage in new strategies so that our nation is not left behind in drug development. Based on past experiences, innovative pathways have been applied in the registration of products of national interest. In fact, the current product registration process allows for expedited review and registration of critical medicinal products to enable sufficient stockpiling in preparation of a health emergency. Additionally, our evaluators have always encouraged a responsible and viable pharmaceutical industry to sustain the healthcare needs of the nation, as guided by the Malaysian National Medicines Policy (MNMP; Dasar Ubat Nasional, DUNas). Nevertheless, Malaysian regulators will need to keep up with global developments, i.e. to establish innovative registration pathways based on our local population needs and through interaction with local product developers in ensuring timely access to essential medicines.

Ladies and gentlemen,

With regards to equitable access to medicines, an unmet medical need among developing nations is the lack of therapeutic agents for diseases confined within these countries. New product pipelines are often dominated by therapies against common diseases in developed countries, a strategy often adopted by drug makers due to a potential of higher return on investment.

The international consortium of healthcare stakeholders has been encouraging the development of treatment agents against diseases commonly encountered in developing nations. Such efforts, however, will not succeed without a shared cause for development among our regulators and product developers, thus reiterating a need to “transform our regulatory practices towards a new paradigm” backed by strong regulatory science. Simply put, a transformation in the our drug regulatory system in the wake of new healthcare challenges will require regulators to work in tandem with all stakeholders in assuring proper medication supply.

On this matter, I am happy to note that the DCA and NPCB do not work in isolation, but rather collaborate regularly with other MOH and governmental entities such as Ministry of Science, Technology and Innovation (MOSTI) and Ministry of Agriculture (MOA), to name a few. In any healthcare system, regular cross talking among its components is crucial in making informed and cost-effective policies.

At the global front, NPCB actively engages in joint projects with counterpart agencies with efforts towards strengthening its regulatory capacity. Regulators often participate in WHO-led meetings, training sessions and evaluation projects for novel products such as endemic vaccines, complex biologics and novel small molecular entities. In the Asia Pacific level, NPCB regulators are a common presence in regional discussions at Asian Pacific Economic Co-operation (APEC) and WHO’s Western Pacific Regional Office (WPRO) forums. The ASEAN Consultative Committee for Standards and Quality – Pharmaceutical Product Working Group (ACCSQ-PPWG) and Product Working Group for Traditional Medicines and Health Supplements (TMHS-PWG) have witnessed efforts towards regulatory convergence bearing early fruits of success in the adoption of an ASEAN Regulatory Framework for Traditional Medicines and Health Supplements (TMHS), emphasising on scientific substantiation on high treatment efficacy and safety claim; bioequivalence and stability of generic pharmaceuticals; and ASEAN specific requirements of biologics.

All these regulatory initiatives contribute to the ultimate aim of building a resilient healthcare system to ensure sustained progress alongside a strong vision of our nation’s healthcare future. For this reason, a radical change is in order to jolt the building blocks of our healthcare system in order to attain higher operational efficiency while pacing the shift in the fundamentals of healthcare delivery. Ultimately, we need to ensure the right care reaches the right patient at the right time.

Ladies and gentlemen,

I am pleased to note the variety of on-trend healthcare topics to be disseminated in this conference. I welcome all Malaysian and overseas speakers and participants and I bid you all a successful engagement. I wish to take this opportunity to thank all individuals, organisations and government agencies for their unwavering support to the Ministry of Health, especially in making this conference possible. I wish to congratulate the organising committee for a job well done and hope the great momentum is sustained in the coming days of NRC 2015.

Thank you.

Datuk Dr Noor Hisham Abdullah

Director General of Health Malaysia