WHO Technical Report Series, No. 981 - World Health Organization

WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report
12.2 Guidance on variations to a prequalified product
In October 2011, the Expert Committee adopted new generic quality guidelines,
published as Annex 4 of WHO Technical Report Series, No. 970, under the title
WHO Guidelines on submission of documentation for a multisource (generic)
finished pharmaceutical product for the WHO Prequalification of Medicines
Programme: quality part. The Expert Committee at that time also proposed
that subsequently a new general document on variations guidelines should be
considered, which would be in line with these newly adopted guidelines. The new
document was mailed out for public consultation in May 2012 and the comments
received were subsequently collated by the secretariat. A revised version was then
mailed out for further comment in August 2012.
The revised document Guidance on variations to a prequalified product
retains the basic structure and function of the previous variations guidelines but
has been completely updated and expanded to bring it in line with the principles
of the new generic quality guidelines.
The Expert Committee adopted the document (Annex 3). It was noted,
however, that the adopted document was intended for use specifically in regard to
PQP and the development of a similar general guidance document on variations
was recommended.
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12.3 Collaborative procedure between the WHO Prequalification
of Medicines Programme and national medicine regulatory
authorities in the assessment and accelerated registration
of national WHO-prequalified pharmaceutical products
The Expert Committee reviewed the draft of a collaborative procedure between
the PQP and NMRAs for the assessment and accelerated national registration
of WHO-prequalified pharmaceutical products. PQP had been approached by a
number of NMRAs seeking assistance with national registration of prequalified
products, which in some cases took a long time, delaying the availability of
medicines to patients.
The aim of the proposed procedure was to accelerate national registration
(marketing authorization) of WHO-prequalified medicines in countries with
participating NMRAs, and to assist NMRAs to focus their regulatory resources
on the country-specific aspects of national registration decision-making.
Given scarce regulatory resources in countries which are recipients of
WHO-prequalified medicines, it was felt that NMRAs in these countries may
benefit from information on the outcomes of assessments and inspections already
organized when they assess prequalified medicinal products. With the agreement
of prequalification holders, PQP would be prepared – under conditions described
in the collaborative procedure – to share full assessment and inspection reports