Publication date: 17 August 2026 Country: Morocco Domain: Medical Devices / Regulation  Morocco is strengthening its regulatory framework applicable to used or refurbished medical devices. A new ministerial order establishes the registration conditions for certain categories of these devices intended to be placed on the Moroccan market.  Devices concerned  The order establishes the registration conditions for certain categories of used or refurbished medical devices, including:  Medical imaging devices  External radiotherapy devices  Brachytherapy devices  Registration remains subject to compliance with the regulatory requirements set out in the order.  […]

Mastering the eCTD Format & New Regulatory Procedures in Tunisia: 2-Day Workshop AREMA is organizing a two-day training workshop dedicated to the eCTD format and the […]

29 July 2026 | Source: Republic of Togo Togo is taking an important step toward strengthening its pharmaceutical regulatory framework. The Togolese authorities are currently finalizing […]

The Tunisian ANMPS has published a new questionnaire addressed to Marketing Authorization Holders (MAHs) as part of the ongoing strengthening of Pharmacovigilance and regulatory compliance activities in Tunisia. This initiative further highlights the importance of maintaining robust local PV oversight and effective regulatory support through qualified local partners.   These two questionnaires were developed to collect accurate and relevant information to guide future actions, improve current practices, […]

AREMA is proud to have participated in ISoP 2025 Cairo – The Leading Annual International Conference in Drug Safety, held from 24 to 27 October 2025 in […]

In June 2025, Tunisia’s National Agency for Medicines and Health Products (ANMPS) released a new official guide titled:  Regulatory Compliance, Reliance, and Pharmacovigilance Guide. The guide outlines the regulatory […]

On June 4th, 2025, the National Agency for Medicines and Health Products (ANMPS) officially published the updated version of the Human Medicines Registration Guide in Tunisia. Download the […]

Arema is pleased to announce its participation in a training session presented with its partner EXTEDO  and in collaboration with the Tunisian National Chamber of the Pharmaceutical Industry (CNIP). […]

The Egyptian Drug Authority (EDA) and the South African Health Products Regulatory Authority (SAHPRA) have announced the reopening of their joint pilot project for the collaborative […]

AREMA is proud to have taken part in the 24th edition of FPI Tunis 2025 event (Forum Pharmaceutique International). FPI Tunis 2025 is a remarkable, huge […]

On April 16, 2025, AREMA will participate in the A3P Tunisia Forum, in partnership with Extedo.  This forum is about:  e-CTD / The new global guidelines […]

Tunisian National Agency for Medicines and Health Products (ANMPS) issued an urgent and important note by 10 April 2025 reminding all pharmaceutical companies to comply with pharmacovigilance […]

In an effort to enhance efficiency and transparency, the Algerian National Agency for Pharmaceutical Products (ANPP) has introduced key digitalization initiatives for the regulatory processes related […]

On January 6, 2025, the International Council for Harmonisation (ICH) adopted the ICH E6(R3) Guideline, introducing significant advancements in Good Clinical Practice (GCP). This updated guideline […]

Senegal and Rwanda have reached a significant milestone by achieving the World Health Organization’s (WHO) Maturity Level 3 in medicines regulation. This status reflects their capabilities […]

In a landmark move, African nations are coming together to address healthcare challenges by establishing a consolidated medicines and vaccines supply network. This initiative, unveiled during […]

The statement regarding the implementation of eCTD has just been published officially by the National Agency for Medicines and Health Products (ANMPS) on the 28th of June 2024.Tunisia is […]

The European Medicines Agency has updated the ICH Q2(R2) Guideline on validation of analytical procedures. The update final adoption was in December 2023 and will come […]

Burundi has new regulatory texts dating from the end of 2023 and the beginning of 2024, the said texts have just entered into force.  These texts […]

During the Council of Ministers in Ivory Coast, Wednesday February 14, 2024, the decree ratifying the Creation of the African Medicines Agency (AMA) was adopted. Once […]