Everyone deserves access to medicines that meet high global standards of quality, safety and efficacy. But when national regulators don’t have the resources to regulate medicinal products in line with these standards, access to supplies of essential medicines is often compromised and delayed. As a result, patients may suffer or die from diseases that are perfectly treatable with the right drugs.
In addition, the lack of effective regulatory market surveillance also feeds the market for substandard and falsified products, leading people to feel that they cannot rely on the medicines in circulation. In fact, an estimated one in 10 medicines circulating in low- and middle-income countries are substandard or falsified, according to the World Health Organization (WHO).
“Poor compliance with good manufacturing practice, limited capacity for technical reviews for marketing authorisations, and limited post-marketing surveillance systems are gaps in the supply system that allow these products to circulate,” says Emer Cooke, head of regulation of medicines and other health technologies at the WHO.
And of the low- and middle-income countries that do have proper legal frameworks for the regulation of medicines, many still face other financial and human resources challenges, according to Margareth Ndomondo-Sigonda, head of health programmes at the African Union-New Partnership for Africa’s Development. “They may not have enough staff, or the competency of the staff is not really in line with what they’re expected to deliver on,” she says, adding that poor coordination between national regulatory institutions can cause further problems.
Many of these issues can be tackled through regulatory convergence and regulatory reliance. The former seeks to align countries or regions around internationally recognised guidance documents, standards, practices and procedures, thereby making it easier for them to collaborate on regulatory decisions. The latter allows regulators to access work done by another regulatory authority or trusted institution, and use that as the basis of their own regulatory decisions.
Sharing information on assessments of new medicines, carrying out joint manufacturing facility inspections and collaborating on post-marketing surveillance of pharmaceutical products means that work isn’t duplicated. “It’s a way of making best use of available resources,” says Cooke. “Leveraging the output of others allows regulators to focus on those activities that they can do best themselves, such as pharmacovigilance and oversight of local manufacturing.”
An increasing number of reliance pathways for work-sharing, medicines assessment and approval are being established globally by regulators within and across geographical regions. This in turn is helping to speed up regulatory decisions and build regulatory capacity in low- and middle-income countries, as well as ensuring timely access to medicines already approved and marketed in higher income countries.
Organisations such as the WHO, the International Coalition of Medicines Regulatory Authorities (ICMRA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use are just as keen as the pharmaceutical industry to see harmonised regulatory standards introduced globally. This will support timely approval processes for new medicines and subsequent post-approval changes to maintain a continuous access to these medicines throughout their life-cycle.
In line with the 2014 World Health Assembly resolution on strengthening the regulatory system for medical products, the WHO has developed the Global Benchmarking Tool for national regulators, which includes regulatory reliance among its criteria for evaluating the maturity of a country’s regulatory system. “It [the tool] has four different maturity levels, but it really assesses the basic effectiveness of the different elements of regulatory functions, with a view to every country having a stable and functional regulatory system,” says Cooke.
National regulators that have reached a certain level of maturity can apply to become a WHO-listed authority (WLA), which means they are globally recognised as meeting WHO and other internationally recognised regulatory standards and practices. National regulatory authorities can have full confidence in the assessments or inspections carried out by WLAs, and trust that any product approved to enter the market by a WLA meets international requirements for safety, efficacy and quality.
Other initiatives include the WHO Collaborative Registration Procedure (CRP), which has sped up the assessment and national registration of both WHO-prequalified medical products and products approved by WLAs. More than 40 countries have now applied the WHO CRP procedure, which has cut the average time for registration of finished pharmaceutical products from between two to five years to under 90 days.
The WHO and other organisations such as the IFPMA, which represents research-based pharmaceutical companies and associations across the globe, are also providing support for the African Medicines Regulatory Harmonisation (AMRH) initiative. The hope is that the work of the AMRH will eventually be incorporated into the African Medicines Agency, which is about to be implemented at a continental level. Ndomondo-Sigonda says the AMRH initially focused on streamlining and harmonising requirements for market authorisation before expanding to tackle other regulatory issues.
To date, numerous national regulators have shared their expertise and insights through regional platforms, carried out joint inspections of facilities and addressed various gaps in their capabilities, which has helped to increase their confidence in working together on regulatory issues.
“All of these measures have increased the efficiency of regulatory processes, and we’ve seen dramatic decreases in the timelines for product availability,” says Cooke.
Through its African Regulatory Network, the IFPMA supports the initiative by advocating regulatory harmonisation, joint dossier assessments and regulatory reliance, and by reflecting pharmaceutical industries’ perspectives during the development of harmonised regulatory guidelines. Moreover, as an AMRH partner the IFPMA also contributes by providing technical expertise in pan-African key priority areas.
Given that more than several thousand medicines are currently in development, many more requests for regulatory approval will be submitted to regulators across the globe in future. Collaboration, convergence and reliance will be key to overcome the regulatory challenges faced in low- and middle-income countries to ensure that everyone, everywhere, has timely access to the medicines they need.
