Medical Products Dossier Evaluation and Registration

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Objectives

The objective is to have harmonized medicines registration system that support public health interventions and ensures timely access to safe, efficacious, quality and affordable medicines for the people of West African region. This will ensure that

  • Medicines Registration Harmonization commences in West African region Member States.
  • A common set of harmonized technical requirements, guidelines, SOPs for medicines registration in the region.
  • Capacity for implementation of medicines registration harmonization in West African region built.

Procedures for Marketing Authorization (MA) in the WA-MRH

  • Currently, the West Africa has no Regional Medicines Regulatory Agency, which has legal mandate for marketing authorization of medicinal products. In view of this, and within the framework of the West African Medicines Regulatory Harmonization (WA-MRH) Initiative, selected medicines in the regional basket will be authorized through the national authorization procedure, after the joint assessment procedure.

National authorization procedure

  • Each ECOWAS Member States has its own procedures for the authorization of medicines, within their own territory, that fall outside the scope of the joint assessment procedure. Information about these national procedures can be found on the website of the National Medicine Regulatory Authority (NMRA) in the country concerned.
  • This procedure will give marketing authorization in ECOWAS Member State(s).

Joint Medicines Dossier Evaluation Procedure

  • This is a procedure for joint assessment by the Expert Working Group on Medical Products Dossier Assessment of the selected medicinal products, inspection of their respective manufacturing site(s) followed by Steering Committee approval of jointly accepted medicinal products.
  • If the assessment of medicinal products dossier is successfully completed and jointly accepted, the ECOWAS Member Sates NMRAs will grant marketing authorization within maximum of three (3) months from the date of joint acceptance.
  • The Marketing Authorization Holder (MAH) can begin to make the medicine available to patients and healthcare professionals in ECOWAS Member States where marketing authorization has been granted.

WHO Collaborative procedure

  • This is a procedure for collaboration between the WHO Prequalification of Medicines Programme (WHO/PQP) and WA-MRH in the assessment and accelerated joint registration of WHO prequalified pharmaceutical products.
  • In this procedure, WA-MRH would voluntarily agree to implement this collaborative procedure and accept the task of processing applications for registration of WHOprequalified pharmaceutical products in accordance with the terms of the Procedure. A list of participating authorities includes:

Scope of products under the WA-MRH Joint Assessment Procedure

  • The scope of medicinal products covered in the joint assessment procedure includes the following:-
  • WAHO’s assessment of the priority health needs in the region;
  • WHO’s evidenced-based treatment guidelines (WHO Essential Medicine List);
  • Programme Medicines: (HIV/AIDS, Malaria, Tuberculosis, Reproductive Health, Neglected Tropical Diseases, Biological Products (Vaccines & Immune Globulins));
  • Medicines used in Public Health Emergencies;
  • Products registered by Stringent Regulatory Authorities, prequalified by WHO, registered under Swissmedic MAGHP Procedure or EMA Article 58 (Positive Scientific opinion);
  • Life Saving Commodities (LSC) by the UN Commission on Life Serving Medicines for Women and Children

How To Submit an Expression of Interest (EOI)

Quality Control Assessment After Submission of an EOI By an Applicant

  • As part of the full evaluation for Market Authorization, quality control assessment of a product will be undertaken to ensure that it meets international quality requirements and is manufactured in compliance with good manufacturing practices (GMP).
  • The procedure for quality control assessment incorporates:
  • General understanding of the production and quality control activities of the manufacturer;
  • Assessment of product data and information on safety, efficacy and quality submitted by the manufacturer, including product formulation, manufacture and test data and results;
  • Assessment of the manufacturing site's adherence to GMP, and its consistency in production and quality control of starting materials, with specific emphasis on active pharmaceutical ingredients and the finished product
  • Assessment of quality control units for compliance with good laboratory practices, as appropriate;
  • Testing of product samples submitted.
  • Previous evaluation conducted by a National Medicines Regulatory Authority (NMRA) within the region may be taken into account during the evaluation conducted by WAHO.
  • Product dossiers that have received WHO pre-qualification or other international regulatory authorities eg. The Food and Drug Authority of the United States (US-FDA) should be presented with evidence and the full package of the approved dossier by the institution.

Dossier Assessment

  • The assessment will be done by Experts Working Group, in accordance with ECOWAS Standard Operating Procedure (SOP) for joint assessment.
  • Dossier assessment shall be done concurrently with Good Manufacturing Practices (GMP) and if applicable, Good Laboratory Practices (GLP) and Good Clinial Practices (GCP) inspections.
  • After review of the assessment report, a meeting (face to face or remotely) will be convened to finalize the reports of the joint assessment. The outcome of the assessment will be shared with WA-MRH Steering Committee for insight and the applicant informed by the Lead coordinating NMRA.
  • If any additional information is required, applicants will be required to provide such additional information to the WA-MRH Secretariat within 60 days, and any extension beyond the specified period should be justified. If no written responses are received within 60 days from the date indicated on the letter, it will be deemed that you have withdrawn the application.
  • Experts Working Group will postpone its decision of the acceptability of the respective product dossier, until such information has been evaluated and found satisfactory in light of the specified standards
  • Upon receipt, the responses to the queries shall be assessed within two months by the Experts Working Group on Medicines Evaluation and Registration.
  • Technical support and expertise from WHO, Stringent Regulatory Authorities, any other technical experts in the area, may be sought in the process of dossier assessment.
  • In the course of assessment all measures will be taken to ensure that confidentiality of the information submitted is protected by all participating Parties.

Site Inspection

  • Site(s) inspection shall be conducted in accordance with the ECOWAS procedure for conducting GMP inspections

Reporting and communication of the results of assessment

  • The team of assessors will finalize its report from the joint assessment session according to the established ECOWAS SOP and format, describing the findings and including recommendations and issues to communicate to applicant, manufacturer(s) and/or testing unit(s) or organization(s), where relevant.
  • The ECOWAS EWG for Dossier Assessment reserve the right to terminate the procedure of assessment of a specific productive the applicant is not able to provide the required information within six months and no written request for extension of time has been submitted.
  • In the event of any disagreement between an applicant and WA-MRH assessment, an SOP established by the WA-MRH for the handling of appeals and complaints will be followed to discuss and resolve the issues.
  • The WA-MRH Steering Committee shall be entitled to use and publish public assessment reports, subject to the protection of any commercially confidential information of the applicant, manufacturer(s) and/or testing organization(s).

Outcome of Joint Assessment Procedure

  • Once the WA-MRH Steering Committee is satisfied that the assessment process is complete for the relevant product, and that the WA-MRH harmonized requirements and standards are met, the product, as produced at the specified manufacturing site(s), a notification letter on completion of assessment of the dossier will be issued by the WAHO Secretariat to the applicant/manufacturer.
  • The letter shall state that the final registration outcome will be communicated by WAHO Secretariat, subject to compliance to all the requirements.

Maintenance of registration status

  • The registered products shall be maintained in WA-MRH and each NMRA’s list of registered products subject to:-
  • Continued compliance with requirements of quality, safety and efficacy.
  • Payment of retention fees in accordance with respective WA-MRH’s Fees.
  • The MAH communicates details to WAHO Secretariat of any changes (variations) made to the registered product following the ECOWAS harmonized guidelines on variations to a registered product.
  • The MAH applies for renewal of their products in accordance with ECOWAS Guidelines on Procedural Aspects for registration of medicinal products.
  • Continued GMP compliance of the manufacturing site(s).
  • Continued compliance with Medicines Health Policies and any other directives.

National approval:

  • After the applicant has submitted the file in the country, the final report is presented for consideration by the internal committee or the National Commission for a final decision.
  • The National Commission shall meet within a maximum period of 30 days after the applicant has submitted the file in the country. A copy of the decision is sent to the MRH Secretariat for information. The market authorization (MA) notification must be made within 30 days of notification of the final decision.

  • TOTAL DAYS = 171 Calendar days (Worst case: 261 days).

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