Algeria, Morocco and Tunisia have fantastic potential for development in the pharmaceutical sector but weaknesses in some aspects of the pharma regulatory system create barriers to market access. Conscious of this, regulatory authorities in the region say they are determined to improve regulatory processes to allow faster access to market for essential and innovative medicines.
That was the overriding message at what was titled the First Regional Conference for Regulatory Harmonisation in Maghreb, which took place in Casablanca in late February. Representatives from national and international regulatory agencies, industry and international governmental and non-governmental organizations shared information on recent regulatory changes and exchanged views around key topics to identify focus areas for future development in the region.
Three main areas of focus were discussed during the conference:
Focus on biosimilars
First, it’s obvious that gray areas in regulatory pathways or their absence are strong barriers to market access for essential and innovative medicines. Taking the example of biosimilars which have the potential to allow wider and more affordable access to medicines due to their lower cost, fresh initiatives are ongoing to formalize a national framework:
- Algeria submitted a draft biosimilars guideline to its experts committee for comments in May 2017; approval is expected this quarter.
- Internal work is ongoing towards a national guideline in Tunisia, where a project to create registration guidelines for biosimilars was initiated in January 2018. The creation of a specialized Commission for Biosimilars, which meets two to three times per year, is expected to accelerate the evaluation of biosimilars.
- In Morocco, there is no specific application procedure for biosimilars as there are no specific local guidelines.
It should be noted that important guidelines were issued in the last two years and numerous legislative instruments are on the way toward finalization which shows the firm intention of regulators in the region to reform the regulatory system and implement efficient changes.
In Algeria, key changes were announced after the creation of the independent regulatory agency including creation of specific regulations on biotherapeutics, biosimilars, herbal preparations and OTC products, and the introduction of a definition for falsified medicines; creation of a national commission in charge of establishing an essential medicines list; a national formulary and national pharmacopoeia; and fast track pathways for innovative products and biosimilars pathways.
The changes should be made official by the new health law currently being debated in Parliament.
The second central theme at the conference was the slowness and absence of predictability of marketing authorization (MA) procedures (initial registration, life cycle management) which limits access to innovative medicines for patients in their respective countries. Several guidelines were issued with a main objective of reducing assessment timelines and implementing predictable procedures.
In Morocco, Decree No. 2-14-841 on Marketing Authorization of Medicinal Products for Human Use, implemented in February 2016, introduced major improvements in the registration process. Important examples include implementation of the “recevabilité” step, which allows providing applicants with clear response on the completeness of the dossier within 60 days and once validated clear timelines are announced for the evaluation / analysis steps that are now conducted in parallel to speed processes. The administration aims at issuing a marketing authorization of a reference product or biosimilar within 10 months and for a generic within nine months.
In Tunisia, the Guidelines Related to Registrations and Variations implemented in May 2016 clarify the procedure for acceptability of files to guarantee complete files at the submission and reduce the number of correspondences (deficiencies). These additions should improve assessment timelines (to be reduced from three years to one year).
In both countries, the variations process was reformed to adopt a risk-based approach with notification only required for minor changes. In Algeria, there is a big hope on the long-awaited independent national pharmaceuticals agency, the Agence National des Produits Pharmaceutiques, or ANPP, which was launched in February 2017 by the Algeria government with a promise to streamline registration processes.
Finally, the harmonization event in Casablanca revived hope for moving forward toward greater partnership and cooperation in the region. In the 2000s, there were initiatives under the umbrella of the Arab Maghreb Union (AMU) (Algeria, Libya, Mauritania, Morocco and Tunisia) for common site inspections and group purchase of medicines and vaccines but the efforts aborted in the context of the instability that the region faces.
The harmonization event in Casablanca revived hope for moving forward toward greater partnership and cooperation in the region.
Harmonization and convergence
Harmonized requirements and convergence are the foundation to take benefit from regulatory cooperation and to share the workload in a context of constrained resources and increasing regulatory requirements. Algeria, Morocco and Tunisia’s guidelines are highly inspired from World Health Organization (WHO), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and European Union (EU) guidelines; however, on the ground there is still significant need for harmonization of scientific requirements to simplify industry and administration routine.
New registration pathways are being developed as part of a worldwide effort to accelerate registration and patient access to new medicines, especially in areas of high unmet medical need. Regulators from three represented authorities admitted that there is a way for future development herein to take benefit from the outputs of other regulatory authorities while safeguarding national sovereignty.
To open the doors Yacine Sellam, of the Pasteur Institute in Algeria, said, “Automatic recognition of approvals is not possible but abridged evaluation could be an option in the future for Algeria.” In this context, countries could be inspired from neighbors in the Middle East that have moved a step forward in relying on approvals in regions or countries with stringent regulatory authorities (such as the European Medicines Agency or the U.S. Food and Drug Administration [FDA]). Learn more in my recent article, “Steps taken to streamline regulatory processes in the Middle East.”