In keeping with a policy of transparency, the DRA should publish guidelines on the data to be provided with the different types of applications. It is not necessary to write a completely new guideline when several such documents exist worldwide. The simplest approach is to adopt the content and format of an already existing guideline, such as that of Canada, the European Union (EU), Japan, South Africa, the United States Food and Drug Administration (FDA) or the International Conference on Harmonisation (ICH) (see box) with, if necessary, modifications to accommodate the local situation. More than one guideline can be adopted, in which case applications may follow either guideline. It will often be appropriate to add technical requirements appropriate to local circumstances, such as requirements for higher temperature and/or humidity data to reflect the climate, or for interchangeability. WHO guidelines are available on most of the technical requirements for multisource pharmaceutical products.
Harmonization of technical guidelines is a desirable goal for following reasons:
X Companies have to generate only one data set for all regions, and consequently the amount of human and animal experimentation is reduced;
X The cost of development of new drugs is reduced, which ought to lead to lower price;
X Local products are more likely to be acceptable for export to other countries.
Some additional experimentation may be necessary for local purposes. For example:
X Studies on interchangeability with locally available products;
X Stability studies under conditions of high temperature and/or humidity (see Annex 11) to verify local applicability;
X Clinical and/or toxicological studies in support of use in endemic diseases;
X Special studies in ethnic groups.
Such studies may be conducted in another country provided that they directly address the local issues and are of a good scientific standard.
ICH (the International Conference on Harmonisation) is an initiative supported by regulatory and industry associations from the three major economic areas of the world, namely the USA, the European Union and Japan. Other parties, such as WHO and the European Free Trade Association (EFTA), are observers. ICH produces guidelines on data requirements for marketing authorization of new chemical entities and biologicals for use in the member regions of ICH. These guidelines are sometimes adopted by other countries for reasons of harmonization.
Other regional groupings are in the process of building up similarly harmonized guidelines, including the Association of South-East Asian Nations (ASEAN) and the Convenio Hipólito Unanue (an agreement between a group of South American nations). |
The guidelines on data to be submitted should be interpreted in a flexible manner. There may be means of establishing quality, safety and efficacy other than those in the guidelines. A general guideline may not be applicable to a particular product. Applicants should have the option of presenting data that are not in conformity with guidelines, but the onus is then on the applicant to demonstrate, by science and sound argument, that the alternative is acceptable. It is not the DRA’s responsibility to make the best of poor data. The DRA should be able to refuse applications which do not meet the guidelines if the case been argued is not sound.
It is usually appropriate to combine guidelines on technical data with those on administrative requirements in a single publication. Technical and administrative guidelines should be readily available on request by potential applicants. A fee may be charged, depending on government policy.
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