AREMA Takes Part in the 4th National Congress of Pharmacology in Tunisia

AREMA Takes Part in the 4th National Congress of Pharmacology in Tunisia

Pharmacovigilance and regulatory developments: AREMA at the heart of professional discussions

On 21, 22 and 23 October 2026, the AREMA team took part in the 4th National Congress of Pharmacology, organized by the Tunisian Association of Pharmacology (ATP) at the Royal Hotels & Resorts in Yasmine Hammamet.

Pre-Congress Training – 21 October 2026

A pre-congress training session focused on “Setting up a pharmacovigilance system in the pharmaceutical industry.” It covered the regulatory and operational aspects of pharmacovigilance, including:

  • case and safety signal management;

  • Risk Management Plans (RMP);

  • Periodic Safety Update Reports (PSUR);

  • pharmacovigilance audits and inspections;

  • practical workshops based on clinical cases and real-life scenarios.

National Congress – 22 and 23 October 2026

The congress featured several plenary sessions on the current challenges and future outlook of the pharmaceutical sector, including:

  • the new Tunisian pharmacovigilance guidelines, as well as the current situation and outlook of global pharmacovigilance;

  • artificial intelligence in modern pharmacovigilance: uses, issues and challenges;

  • regulatory updates on the bioequivalence of medicinal products for human use;

  • the role of regional pharmacovigilance centers within the National Agency for Medicines and Health Products (ANMPS).

Key Regulatory Developments in Tunisia Highlighted at the Congress

Discussions on the Tunisian regulatory framework highlighted two topics of interest for pharmaceutical professionals: the draft Tunisian Good Pharmacovigilance Practice guidelines and the revision of the guideline on the bioequivalence of medicinal products for human use.

Draft Tunisian Good Pharmacovigilance Practice Guidelines

According to information shared during the discussions, the draft Tunisian Good Pharmacovigilance Practice guidelines are reportedly being finalized. They would comprise 16 modules: modules 1 to 11 would have been revised, while modules 12 to 16 would be new.

Inspired by the European regulatory framework, the draft would aim in particular to clarify the requirements for pharmacovigilance activities, Risk Management Plans (RMP), Periodic Safety Update Reports (PSUR) and regulatory submission deadlines.

Their finalization and publication will be important milestones for pharmaceutical companies to follow. They will allow the professionals concerned to assess any adjustments that may be needed to their systems, internal procedures and compliance practices.

The final content and the publication timeline remain to be confirmed by the competent authorities.

Revision 2 of the Bioequivalence Guideline for Medicinal Products for Human Use

The Tunisian guideline on the bioequivalence of medicinal products for human use already exists (2018 version) and is currently being revised for its second version (Revision 2).

According to information shared during the discussions, the revision work is ongoing. A preliminary version (draft) may be made available so that stakeholders can review the proposals and, where appropriate, submit their comments.

Monitoring the revised version will help professionals anticipate potential changes and assess their impact on regulatory activities and on the development programs concerned.

The publication of the draft version, the final content of the revision and its timeline remain to be confirmed.

AREMA’s participation in this event is part of its commitment to the continuous training of its team, regulatory monitoring and support for pharmaceutical professionals. It reflects AREMA’s commitment to following regulatory developments, anticipating new requirements and helping strengthen professional practices, in order to better support its clients.

AREMA thanks the Tunisian Association of Pharmacology (ATP), Professor Riadh Daghfous and the entire team of the National Pharmacovigilance Center for organizing this major event and for the quality of the discussions, which foster knowledge sharing and the development of pharmacovigilance in Tunisia.