English — reviewed original text

MEDICINES CONTROL AGENCY MCA THE GAMBIA CLINICAL TRIAL APPLI- MCA-F-501/01 CATION FORM MEDICINES CONTROL AGENCY Off Bertil Harding Highway, Kotu East, Kanifing Municipality, P.O. Box 3162, Serekunda, The Gambia Website: www.mca.gm; E-mail: info@mca.gm; Tel. No.: +2204380632 *Write NA if an item is not applicable Section 1: Trial identification Other countries to which the applica- tion is submitted PACTR1 number Trial title Trial short title where available Protocol number, date, and version2 Phase of the trial (if applicable) If applicable: additional public regis- try trial identifiers: clintrials.gov, EudraCT, etc 1 Pan African Clinical Trials Registry 2 Any translation of the protocol should be assigned the same date and version as those in the original document Section 2: Regulatory details Name of other Regulatory Authorities and Ethics Committees to which this application has been submitted, and/or approved If applicable, explain why the trial is not going to be conducted in the host country of the sponsor If applicable, name of other Regula- tory Authorities and/or Ethics Com- mittees that have rejected this trial and explain If applicable, provide details and ex- plain why this trial was halted at any stage by other Regulatory Authorities and/or Ethics Committees MCA-F-501/01, version 2 – 24 January 2025 Page 1 of 8

Clinical Trial Application Form MCA The Gambia Section 3: Identification of the Sponsor(s) Sponsor Name of the organisation Name of the contact person(s) Address Telephone number E-mail Website (if applicable) Funding body(s) (if different from Sponsor) Name of the organisation Name of the contact person(s) Address Telephone number E-mail Website (if applicable) Sponsor’s representative Name of the organisation Name of the contact person Address Telephone number E-mail Status ☐ Commercial ☐ Non-commercial Website (if applicable) Monitor Name of the organisation (if other than Sponsor or Sponsor’s repre- sentative) Name of the contact person Address Telephone number E-mail MCA-F-501/01, version 2 – 24 January 2025 Page 2 of 8

Clinical Trial Application Form MCA The Gambia Section 4: Applicant identification State who is submitting the applica- tion: Sponsor, Sponsor's representa- tive or Principal Investigator Name of the organisation Name of the contact person Address Telephone number E-mail Section 5: Investigators' details Coordinating Investigator for multicentre trials (if applicable) Name Qualification (Medical doctor, other) Professional address Telephone number E-mail Principal Investigator in The Gambia Name Qualification (Medical doctor, other) MDCG Registration number (if re- sponsible medical doctor): Professional address Telephone number E-mail Clinical Trial Coordinator (where appointed by Principal Investigator) Name Qualification (Medical doctor, other) Professional address Telephone number E-mail Principal Investigator(s) of other sites (if applicable) - repeat as necessary Name MCA-F-501/01, version 2 – 24 January 2025 Page 3 of 8

Clinical Trial Application Form MCA The Gambia Qualification (Medical doctor, other) Professional address Telephone number E-mail Responsible Medical Doctor (if different from PI) Name MDCG Registration number: Professional address Telephone number E-mail Investigator(s) listed in the protocol (if applicable) - repeat as necessary Name Qualification (Medical doctor, other) Professional address Telephone number Fax number E-mail Section 6: Details of Trialists and Sites Details of the site(s): name, physical address, contact details, contact per- son including telephone and email contacts Details on the staff (Clinical Trial team) at the site (number, qualifica- tion and roles) Evidence of the Lab(s) competences: Name and address of responsible Lab Manager Section 7: Information on the Investigational Medicinal Product/s (IMP)/Investigational Product/s (IP)3 Indicate if the information refers to the IMP/IP being tested or to the IMP/IP used as a comparator4 - re- peat as necessary MCA-F-501/01, version 2 – 24 January 2025 Page 4 of 8

Clinical Trial Application Form MCA The Gambia Status of the IMP/IP Is the IMP/IP prequalified5 by WHO? Does the IMP/IP have a registration in any country? If yes, provide the trade name, name of the marketing authorisation holder and the country that granted regis- tration. Is registration6 in Africa envisioned? For the purpose of this trial, is the IMP/IP modified in relation to its reg- istration? IMPD or equivalent submitted: • IMPD • Summary of Product Characteris- tics (SmPC) or other Professional Product Information Has this IMP/IP been previously au- thorised in a clinical trial conducted by the Sponsor in Africa? If so, provide the Authority's name, date, approval number (if available), trial title, protocol number, [national] Principal Investigator, and date of the final report (if available) Description of the IMP/IP Product name or identification number ATC code of IMP if it has a marketing authorisation Pharmaceutical form of IMP Pediatric formulation of IMP? ☐ Yes ☐ No Maximum duration of treatment of a patient/participant according to the protocol Dose of IMP allowed: • First dose for first-in-human trials, specify per day or total dose; units and route of administration • Maximum dose allowed, specify per day or total dose; units and route of administration MCA-F-501/01, version 2 – 24 January 2025 Page 5 of 8

Clinical Trial Application Form MCA The Gambia Estimated quantity of IMP/IP required for the trial (including overage7) Route of administration/application Name of each active substance of IMP (INN or proposed INN, if availa- ble) Strength of IMP (specify all strengths to be used): • Concentration unit • Concentration type (exact number, range, more than, or up to) • Concentration (number) • Unit of issue Type of IMP/IP Does the IMP contain an active sub- stance of chemical or of biological/ biotechnological origin? Is the IMP? • Immunological product (vaccine, allergen, immune serum) • Plasma derived product • Recombinant product • Radiopharmaceutical product • Herbal medicinal product • Other, specify Is the IP? • Medical device • Cosmetic • Homeopathic medicine Other, specify 3 Present this information for each and all investigational (medical) products to be used in the trial 4 Include a justification for choosing this comparator 5 Provide the corresponding evidence 6 If more than one IMP/IP is being tested, indicate for which IMP/IP marketing au- thorisation (registration) is envisioned, if applicable 7 Provide a justification if the overage is higher than 20% Section 8: Medical condition or disease under investigation Medical condition/disease to be in- vestigated; summarise the local epi- demiology (up to 100 words) MCA-F-501/01, version 2 – 24 January 2025 Page 6 of 8

Clinical Trial Application Form MCA The Gambia Therapeutic area Section 9: Scope of the trial Diagnosis Prophylaxis Therapy Safety Efficacy Other, explain Section 10: Trial type Human pharmacology (Phase I) Human pharmacokinetics First-in-humans Bioequivalence Other, specify Therapeutic exploratory (Phase II) Therapeutic confirmatory (Phase III) Therapeutic use (Phase IV) Other, specify Section 11: Trial duration and recruitment Total duration of the study includ- ing follow-up Envisioned number of participants globally Envisioned number of participants nationally Envisioned number of participants per site in the country to which the application is being submitted DECLARATION BY THE APPLICANT I, the undersigned have submitted all requested and required documentation, and have disclosed all information that may influence the approval of this application. I, hereby declare that all information contained therein, or referenced by, this ap- plication is complete and accurate and is not false or misleading. MCA-F-501/01, version 2 – 24 January 2025 Page 7 of 8

Clinical Trial Application Form MCA The Gambia I, the undersigned will ensure that if the above-said clinical trial is approved, it will be conducted according to the protocol submitted, and all applicable legal, good clinical practice, ethical and regulatory requirements. Signature of Applicant Name Signature Date OFFICIAL USE Date received: MCA CT Number: Comments MCA-F-501/01, version 2 – 24 January 2025 Page 8 of 8