(2004; 140 pages)
Appendix 4 - Format of the Summary of Product Safety and Efficacy
The purpose of the Summary of Product Safety and Efficacy is to provide current information on the safety and efficacy of the product in support of the information provided in the Package Leaflet and Summary of Product Characteristics. The summary should be 4 - 6 pages long (or more as appropriate, in case of a multisource product where no innovator or comparator/reference product is available) and should be written in easily understandable English to be useful to all interested parties.
The summary should provide an integrated evaluation of the product and not just a summation of the product information for the individual actives contained in e.g. - fixed dose combinations. Similarly for such products the rationale for use of the product should be in terms of the combination. Further guidance is provided in the WHO "Guidelines for Registration of Fixed Dose Combination Medicinal Products"1 (September 2004).
The outline for the Summary of Product Safety and Efficacy should follow the format described below:
b. Product Design
c. Unique product characteristics
d. Approved indication(s)
2. Clinical pharmacology
i. Special populations
3. Drug Interactions; related side effects and contra indications
4. Clinical Efficacy
a. Controlled studies
b. Observational studies
c. Supportive studies
d. Clinical studies in special populations
i. Kidney dysfunction
ii. Liver dysfunction
For each population information should be presented by patient categories as relevant to the FPP e.g. for FDC's antiretroviral naïve - and experienced patients.
5. Clinical Safety
a. Patient exposure
b. Serious adverse events/deaths
c. Adverse events
6. Benefit risk assessment
For documents referenced in the Summary, e.g. scientific articles, copies of the underlying documentation should be provided.