DESCRIPTION OF CHANGES MADE TO THE REVISED COMPENDIUM OF GUIDELINES FOR MARKETING AUHORIZATION OF MEDICINAL PRODUCTS

1. The Compendium of Guidelines for Marketing Authorization of Medicinal Products was developed following the review of existing guidelines for registration of human medicines with the aim of updating the requirements in line with international best practices and addressing various challenges presented by our stakeholders.
2. The Compendium of Guidelines incorporates new templates, additional information requirements for product labels, minor updates to existing guidelines as well as introduction to two new documents that is Quality Information Summary (QIS) template and Guidelines on Naming of Medicinal Products. Additionally, three new terminologies, “extension applications”, “duplicate license” and “unique identifier” have been introduced. An overview of the changes is delineated below: -

   1. Quality Information Summary (QIS)

      The QIS provides an accurate record of technical data in the dossier at the time of assessment and thereafter serves as an official reference document during the course of GMP inspections, variation and renewal assessments as performed by TMDA. The QIS is a condensed version of the Quality Overall Summary – Product Dossier (QOS-PD) and represents the final, agreed upon key information from the product dossier review (inter alia identification of the manufacturer(s), API/FPP specifications, stability conclusions and relevant commitments). The QIS template should be completed to provide a condensed summary of the key quality information for product dossiers containing APIs and their corresponding FPPs.

      The QIS should be revised and submitted with the change history in Word format, each time an additional data (query response) is provided during the assessment process and thereafter when submitting variation and renewal applications for registered products.

      The QIS document template is appended as Annex IV of the Compendium of Guidelines for Marketing Authorization of Medicinal Products. The QIS template should therefore be completed for each application to provide a condensed summary of the key quality information for product dossiers containing APIs and their corresponding FPPs.

   2. Guidelines on Naming of Medicinal Products

      The guidelines have been developed and included as Part XI in the revised Compendium of Guidelines. This guideline provides requirements for proposing appropriate brand names for the medicinal products intended to be marketed in Tanzania.

   3. Extension applications

      This has been incorporated within Part X: Guidelines on Procedural Aspects for Applications for Marketing Authorization of Pharmaceutical Products with the aim of providing an option for abridged documentation and evaluation of medicinal products that are essentially a modification of already registered medicinal products. This includes modifications that do not fulfil criteria for minor or major variations but are similar enough to the original product in terms of quality, safety and efficacy.

   4. Duplicate license

      This has been incorporated within Part X: Guidelines on Procedural Aspects for Applications for Marketing Authorization of Pharmaceutical Products in order to allow a marketing authorization holder to grant the use of their product information to another marketing authorization holder. Also, it allows the same applicant to submit more than one application for a finished product under different brand names.

   5. Unique identifier

      This has been added as a security feature on the product labels for market surveillance purposes. A unique identifier is any unique code that specifically identified and captures particulars of the product. It may be in form of a code, barcode, security number that is unique for a specific product or the registration number issued by TMDA.

3. Other changes incorporated into the Compendium are as follows:
   1. The bioequivalence trial information form (BTIF) has been updated and a reference to the WHO list of international comparators for pharmaceutical products within the Guidelines on Therapeutic Equivalence Requirements has been added; and
   2. Detailed requirements for product labeling and package inserts within the Guidelines on Format and Content of Labels for Medicinal Product and the Guidelines on Format and Content of Package Inserts for Medicinal Product have been included.
4. Please note that, the individual guidelines for registration of veterinary medicines, herbal medicines, vaccines and biotherapeutics including biosimilars remain as independent documents. Nevertheless, several parts of the Compendium may be applicable to these products and refereed to when compiling submissions. Parts of the Compendium that cater to all medicinal products include:
   1. Guidelines on Procedural Aspects for Applications for Marketing Authorization of Pharmaceutical Products;
   2. Guidelines on Naming of Medicinal Products;
   3. Guidelines on Format and Content of Labels for Medicinal P roducts; and
   4. Guidelines on Format and Content of Package Inserts for Pharmaceutical products.
5. It is anticipated that these guidelines will be revised periodically in response to the feedback obtained following its implementation. Therefore, we welcome comments and inputs which will assist in improving the guidelines.