Zambia Medicines Regulatory Authority

1 Zambia Medicines Regulatory Authority APPLICATION FOR MARKETING AUTHORISATION. OF A medicine FOR HUMAN USE. COMMON TECHNICAL DOCUMENT FORMAT. Zambia Module 1. CTD-Modules 2 - 5. Version 03, April 2015. Zambia Common Technical Document Modular format of applications for registration in CTD format .. 4. Zambia Module 1 Administrative information and prescribing information .. 4. Cover Letter .. 4. Comprehensive table of contents .. 4. Application 4. Labelling and packaging .. 4. Information about the experts.

2 4. Specific requirements for different types of applications .. 4. Environmental risk assessment .. 4. Good manufacturing practice .. 4. Details of Screening .. 5. Individual patient data - statement of availability, if applicable .. 5. Foreign Regulatory status .. 5. Regional Summaries .. 5. Paediatric development programme .. 6. Information relating to 6. Electronic review documents ( product information, BTIF, QOS) .. 6. Sample and Documents ( FPP, device(s), certificates of analysis) .. 6. Module 2 - CTD Summaries.

3 6. CTD Table of Contents (modules 2 to 5).. 6. Introduction .. 6. Quality Overall Summary - Introduction .. 6. Non-clinical Overview .. 7. Clinical Overview .. 7. Non-clinical Written and Tabulated Summaries .. 7. Clinical Summary .. 8. Module 3 - Quality .. 10. Table of contents of module 10. Body of data .. 10. Drug Substance / Active Pharmaceutical Ingredient (name, manufacturer) .. 10. Drug Product / Pharmaceutical Product (name, dosage form).. 11. Appendices .. 12. Regional 12. Literature references.

4 12. Module 4 - Non-clinical study reports .. 12. Table of contents of Module 4 .. 12. Study reports .. 12. Literature references .. 13. Module 5 - Clinical Study Reports .. 13. Table of contents of Module 5 .. 13. Tabular listing of all clinical studies .. 13. Page 2 of 14. Clinical study reports .. 13. Literature references .. 14. Page 3 of 14. Modular format of applications for registration in CTD format Zambia Module 1 Administrative information and prescribing information Cover Letter Comprehensive table of contents Application Information Application form Letter of authorisation for communication on behalf of the applicant Electronic copy declaration Copy of certificate for a Vaccine Antigen Master File (VAMF).

5 Copy of certificate for a Plasma Master File (PMF). Copy of certificate(s) of suitability of the European Pharmacopoeia (CEP). Copy of confirmation of API prequalification document (CPQ). Letter of access from APIMF, CEP or CPQ holder Labelling and packaging Package Insert Summary of Product Characteristics (SmPC). Patient Information Leaflet (PIL). Labels (outer and inner labels). Braille Information about the experts Quality Non-clinical Clinical Specific requirements for different types of applications Studies and data for generic products Environmental risk assessment Good manufacturing practice Date of last inspection of each site Inspection reports or equivalent document Latest GMP certificate (not older than 3 years)

6 For API and FPP manufacturer/s and packer/s or a copy of the appropriate manufacturing licence Registration of Responsible Pharmacist or Suitably Qualified Person for local manufacturers Certified copy of a permit to manufacture specified controlled substances Page 4 of 14. Details of Screening Individual patient data - statement of availability, if applicable Foreign Regulatory status List of SADC or other countries in which an application for the same product as being applied for has been submitted, registered, rejected or withdrawn.

7 WHO type Certificate of Pharmaceutical Product (COPP). Registration certificate or marketing authorisation Foreign prescribing and patient information Data set similarities Regional Summaries Summary of the Bioequivalence Studies Study Title(s) (or brief description giving design, duration, dose and subject population of each study). Protocol and study numbers Investigational products (test and reference) details Confirmation that the test product formulation and manufacturing process is that being applied for Name and address of the Research Organisation(s) / Contract Research Organisation(s) where the bioequivalence studies were conducted Page 5 of 14.

8 Sponsor and responsible sponsor representative: name and address, contact details Duration of Clinical phase: dates of dosing and last clinical procedure Date of final report Biostudy reference product confirmation Certificates of analysis of the test and reference products Bioequivalence trial information form (or BTIF). Biowaiver requests in relation to conducting comparative bioavailability study Quality Information Summary (QIS). Paediatric development programme Information relating to Pharmacovigilance Pharmacovigilance system Risk management system Electronic review documents ( product information, BTIF, QOS).

9 Sample and Documents ( FPP, device(s), certificates of analysis). Confirmation of submission of sample Certificate of analysis of the sample Module 2 - CTD Summaries CTD Table of Contents (modules 2 to 5). Introduction Quality Overall Summary - Introduction Quality Overall Summary Drug Substance / Active Pharmaceutical Ingredient (name, manufacturer). General Information (name, manufacturer). Manufacture (name, manufacturer). Characterisation (name, manufacturer). Control of Drug Substance /Active Pharmaceutical Ingredient (name, manufacturer).

10 Reference Standards or Materials (name, manufacturer). Container Closure System (name, manufacturer). Stability (name, manufacturer). Quality Overall Summary Drug Product / Finished Pharmaceutical Product (name, dosage form). Description and Composition of the Drug Product / Pharmaceutical Product (name, dosage form). Page 6 of 14. Pharmaceutical Development (name, dosage form). Manufacture (name, dosage form). Control of Excipients (name, dosage form). Control of Drug Product / Pharmaceutical Product (name, dosage form).