In May 2013, the WHO released its new Technical Report (TRS 981) including 4 Annexes entitled:
We reported about the content of Annex 2 in our GMP News from 19 June 2013.
Annex 3 is composed of a Variations Guideline which has been updated to take into consideration the provisions laid down in the new WHO Generic Guideline (see our GMP News from 3 April 2013). The complete title of this Variations Guideline is "WHO guidelines on variations to a prequalified product" and applies to prequalified APIs and medicinal products. This guideline thus belongs to the range of documents which form the regulatory framework to the prequalification programme of the WHO.
The new Variations Guideline intends to provide guidance with respect to the classification of administrative and quality-related changes as well as to changes in a Certificate of Suitability (CEP) or in the prequalification documentation of an API.
The guideline addresses 2 variation categories:
For changes which could have minimal or no adverse effects on the overall safety, efficacy and quality of the medicinal product, the Guideline categorizes:
The list of each change is - analogous to the new Variations Guideline of the EU Commission (please see the following GMP News in this Newsletter on the final Variations Guideline), is presented in tabular form too.
The WHO prequalification programme includes the prequalification of APIs, finished medicinal products, QC labs and is limited to medicinal products used for HIV/AIDS, malaria, tuberculosis and for reproductive health. To obtain prequalification for an API or a medicinal product, the applicant has to submit a dossier in the CTD format which - comparable to an authorisation in Europe - proves the quality, efficacy and safety of the medicinal product. Further information about the prequalification programme can be found on the WHO website.