News

IMPLEMENTATION OF eCTD IN TUNISIA

The statement regarding the implementation of eCTD has just been published officially by the National Agency for Medicines and Health Products (ANMPS)  on the 28^th of June 2024.
Tunisia is set to implement eCTD in 2025, with a transition period for online submissions (eSubmission), starting in January 2025. The full implementation is planned for 2026, with no paper submissions allowed after this date.

This move aims to optimize patient access to innovative treatments and reduce administrative processes.

Congratulations to Tunisia and the new agency for this achievement as Tunisia is the 2^nd country in Africa to implement eCTD (after South Africa).

For more information, you can find the document published by the agency: 

http://www.dpm.tn/images/pdf/Communique-28062024.pdf

Burundi: New regulations for Medicines/Medical devices

Ivory Coast joins the African Medicines Agency (AMA)

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 this decree is signed and deposited in Addis Ababa, Ivory Coast will officially become a confirmed Member State of the AMA. This convention aims to harmonize the regulatory systems for medical products in Africa, with a view to eradicating the proliferation of falsified and substandard pharmaceutical products. 

For more information, please consult the official portal of the government of Ivory Coast::

 https://www.gouv.ci/_conseil-ministre-details.php?recordID=482

Actualization of the ICH Q2 (R2)

The European Medicines Agency to support establishment of the African Medicines Agency

On the 26^th of January 2024, the European Medicines Agency (EMA) has received a grant of ten million euros from the European Commission to support the establishment of the African Medicines Agency (AMA).

The AMA, a specialized agency of the African Union, aims to improve access to quality and safe medical products in Africa. EMA will share its expertise and regulatory model with AMA to help regulate medicines efficiently and effectively. This collaboration is part of the 'Team Europe' initiative to strengthen regulatory capacity in Africa.

For more information, you can visit the European Medicines Agency website: https://www.ema.europa.eu/en/news/ema-support-establishment-african-medicines-agency#:~:text =EMA%20has%20received%20a%20grant,African%2C%20European%20and%20international%20actors.

ARAB HEALTH 2024

AREMA top management will be visiting ARAB HEALTH from 29 January to 1 February, 2024
AREMA with our unparalleled experience globally and especially with local representation in over 20 countries in AFRICA and MENA region , we are committed to close collaboration with you, sharing our profound expertise, and offering solutions and services aligned with your current projects and future development.

👋 We would be glad to meet your decision-maker(s) or representative(s) during ARAB HEALTH from January 29 to February 1, 2024. Please don’t hesitate to ask for a meeting through our email: info@arema-international.com

 

Introduction of the eCTD in the ECOWAS region

The Economic Community of West African States (ECOWAS) published in August 2023, a new guide called “Approval of pharmaceutical products for human use in the Economic Community of West African States”.

This guide will strengthen the harmonization of the regulatory system and will apply to all applications using the electronic format of the ECOWAS Common Technical Document (eCTD) for all centralized procedures.

This version 1.0 of ECOWAS eCTD Specification is based on ICH eCTD version 3.2.2. The document contains:

• Guidelines on the structure of an ECOWAS eCTD Application
• Guidance on the creation and validation of your ECOWAS ETD Sequences

The submission with version 1.0 of the eCTD will be accepted from November 1, 2023, and will become mandatory from May 1, 2026.

For more information, please visit the official ECOWAS eCTD page: https://ectd.wahooas.org/

Creation of the National Agency for Medicines and Health Products of Tunisia

On July 12, 2023, Tunisia published in the Official Gazette of the Republic of Tunisia (JORT) an important law, Law No. 2 of the year 2023, establishing the "National Agency for Medicines and Health Products ".

The National Medicines Agency is a non-administrative public institution. It is responsible for several missions, mainly the proposal of management policies for medicines and health products as well as the responsibility for granting authorizations for the manufacture, registration, marketing, import and export of these products. It will also play a major role in the quality control of medicines, food supplements, cosmetics, and others.

In practice, this new agency will mainly bring together the following administrations, namely: The Directorate of Pharmacy and Medicine (DPM), the National Center for Pharmacovigilance (CNPV), the National Medicines Control Laboratory (LNCM) as well as the Directorate pharmaceutical inspection (DIP).You can view the JORT law via this link: http://www.iort.gov.tn/WD120AWP/WD120Awp.exe/CTX_9232-6-qfOPckEEEv/RechercheTexte/SYNC_-907551134

United Conference of Generic Medicine, Vaccines and Biosimilars

9 April 2021: Zina Kobbi CEO of AREMA will be the Keynote Speaker on the virtual conference “United Conference of Generic Medicine, Vaccines and Biosimilars” to talk about “Biosimilar Regulatory and Development Considerations in North African Countries.”

New Bioequivalence guideline Morocco

New guideline of bioequivalence was recently implemented in Morocco by the drug agency, Ministry of Health the link to the document: http://dmp.sante.gov.ma/upload/uploadinterne/Lignes%20directrices%20bioequivalence%20Maroc.pdf .

COVID 19 African Situation

Africa must "wake up" to the coronavirus threat and prepare for the worst, the head of the World Health Organization (WHO) DrTedros has said! Due to economic conditions, overcrowding and poor healthcare system many people across Africa feel vulnerable. The Africa Center for Disease Control and Prevention said Thursday that until now 46 out of 54 African countries have reported cases of Covid-19. Africa seems to be the continent's Coronavirus challenge! .

Medical devices Burkina Fasso

News regulation and requirements for medical devices dossier preparation for registration in Burkina Fasso .

SFDA New regulation of marketing exclusivity

News of Saudi Food and Drug Authority June 2019: “regulation of marketing exclusivity” : this new procedure aims to promote the availability of the important pharmaceutical products in Saudi Arabia, “marketing exclusivity” is granted for a maximum two companies per product for specific period. SFDA publish the list of the pharmaceutical products that are eligible for marketing exclusivity. .

Partnership between Europe and Africa for clinical trials

Le partenariat entre l’Europe et les pays en voie de développement pour les essais cliniques (EDCTP) accorde un financement de 10 millions d’euros sur cinq ans pour le projet « WANECAM 2 » Cette subvention va soutenir les essais cliniques en Afrique sur une nouvelle combinaison antipaludique, KAF156 (ganaplacide) et luméfantrine, à prise unique quotidienne. Le composé KAF156 a démontré qu’il avait le potentiel de traiter le paludisme résistant et pouvait être administré sous la forme d’une dose unique. La subvention contribuera également à construire et renforcer les capacités de recherche dans les quatre pays participants : Burkina Faso, Gabon, Mali et Niger. .

20ème Réunion Ordinaire de l’Assemblée des Ministres de la Santé de la CEDEAO

La 20ème Réunion Ordinaire de l’Assemblée des Ministres de la Santé de la CEDEAO (AMS) aura lieu du 29 avril au 3 mai 2019 à Cotonou en République du Bénin. L'Assemblée des Ministres de la Santé de la CEDEAO (AMS) est un événement annuel important pour la région de la CEDEAO pour la prise de décision dans le domaine de la santé. Les Pays concernés: Bénin Burkina Faso Cabo Verde Côte d'Ivoire Gambia (The) Ghana Guinée Guiné-Bissau Liberia Mali Niger Nigeria Sénégal Sierra Leone Togo .

AREMA New services

New : AREMA as a company specialized in Regulatory Affairs, registration & business development opportunities in Africa (17 countries), enlarge alliances and services and offer now regulatory affairs and registration in CIS countries (12 countries) : Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Ukraine and Uzbekistan. For more information contact us at: info@arema-international.com .

eCTD

Discover our new service and offer for eCTD! .

AREMA at CPHI WORLDWIDE from 9 to 11 October

AREMA will be visiting CPHI WORLDWIDE (from 9 to 11 October). If you wish to meet AREMA representative and know more about our services , please contact us directly at: info@arema-international.com to book an appointment. .

WHO Pilot Procedure for Prequalification of Rituximab / Trastuzumab

05 July 2018: WHO launched a pilot project for prequalifying biotherapeutic medicines, a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income countries. To that end, WHO is inviting manufacturers to submit applications for prequalification of two biotherapeutic products: Rituximab (used principally to treat non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia), and Trastuzumab (used to treat breast cancer) and their corresponding similar biotherapeutic products. For more information: http://www.who.int/medicines/regulation/biotherapeutic_products/en/ .

SFDA, Good Manufacturing Practice for Blood Establishments.

SFDA (Saudi Food & Drug Authority) adopted on 06 June 2018 , Good Manufacturing Practice for Blood Establishments. The purpose of this document is to provide guidance for GMP-inspectors and useful information for blood establishments relating to the collection, preparation, storage, dispatch, quality control and quality assurance of blood and blood components. For more information here is the Link to the complete document: https://www.sfda.gov.sa/en/drug/drug_reg/Regulations/DrugGMPBloodEstablishments.pdf .

FDA approves first biosimilar to Neulasta (pegfilgrastim)

04 June 2018: FDA approves first biosimilar to Neulasta (pegfilgrastim) of Mylan GmbH. This porduct helps to reduce the risk of infection during cancer treatment . The FDA’s approval of Fulphila is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates Fulphila is biosimilar to Neulasta. Fulphila has been approved as a biosimilar, not as an interchangeable product. .

African Economic Forum

Tunisia Hosts African Economic Forum on 24 and 25 April 2018 .