In a globalized world, the regulatory landscape is changing every day to address, in tandem, old and new challenges. With regulatory systems increasingly under pressure globally, what will be the most promising weapons in the fight to make regulatory systems in Africa work more efficiently? And how to pay the bill for the extensive regulatory capacity building needed for the region? What is required so that current and future generations in Africa can access quality innovative medicines and vaccines in a timely manner to sustain healthier societies? These questions are precisely what the IFPMA, the Drug Information Association (DIA), in sponsorship with the Bill & Melinda Gates Foundation and the World Bank have on the agenda for the 4th Africa Regulatory Conference taking place on 27 – 28 April in Dakar, Senegal.
New technology and progress, breakthrough medicines and vaccines are entering the healthcare system every day at a different stage of maturity. In response to this, national regulators on every continent, including Africa, are adjusting their regulatory paradigm with new mechanisms for the timely and effective assessment of benefit-risk of such products to public health. What is very challenging from an industry perspective is simply put this way: regulatory requirements can be very different from one country to another, which may jeopardize timely access for patients to the new treatments we deliver.
A case in point is the redundant testing and delayed access to medicinal products in general, with a special emphasis, as illustrated here for vaccines. As one may know, the quality of vaccines is confirmed via the extensive testing that is performed during the manufacturing process. The product is also tested for lot release by the official control laboratory in the country of manufacture. Additional testing in the importing country may be required which will then delay further the availability of the vaccine in-country. Typically these tests are performed consecutively. The remaining shelf life of a vaccine is directly affected by the time taken for testing. Prolonged testing means less time for the distribution and administration of the vaccines for patients.
What is needed for securing timely access to life-saving treatments is building the foundation of a sustainable regulatory environment that may include the following: moving towards convergence of standards, collaborating with well-resourced regulatory authorities with relevant expertise to rely on assessments already made, leveraging appropriate use of World Health Organization Prequalification to accelerate local review and authorization, and enhancing regional cooperation to leverage complementary expertise. All this is with the aim of making best use of limited resources while still supporting other essential regulatory functions to ensure adequate quality, safety and efficacy oversight.
So if we look closer to the upcoming ARC, the 2-day event will kick off with a special training course on pharmacovigilance on 26 April. The main conference will then run from 27-28 April, followed by a one-day workshop on counterfeit medicines on 29 April. The ARC will attract a broad cross section of key regulatory stakeholders committed to improving access to safe and quality medicines in Africa, including industry, policy-makers, researchers, governmental and non-governmental organizations.
The conference will provide participants with an opportunity to get an update from regulatory agencies on the African Medicines Regulatory Harmonization (AMRH) program which is leading the regulatory convergence efforts within the continent. Good review practices and regulatory convergence; improvement in Good Manufacturing Practices compliance; opportunity for pragmatic dialogue between medicines regulatory authorities and industry; how to tackle the challenges encountered in clinical trials and related capacity building in Africa, are all topics on which the ARC aims at providing comprehensive elements of information, and much more.
About African Regulatory Network
The ARN is an ad-hoc network of the Regulatory Policy and Technical Standards Committee (RPTS) of IFPMA. The Network works in partnership with regulatory authorities and the pharmaceutical industry in Africa to encourage greater harmonization of regulatory requirements with the aim to help enable faster and expanded access to good quality innovative medicines for patients.