(1999; 168 pages) [Spanish]
Defining the scope of the marketing authorization procedure for medicinal products
This section complements the "Guiding principles for small national drug regulatory authorities" published by WHO (2).
The formulation of laws and regulations to define and control the national market in medicinal products is discussed elsewhere. In this section the scope of the application of the authorization/licensing system is discussed, with particular reference to finished medicinal products.
The prime objective of every national drug regulatory system is to ensure the safety, quality and efficacy of medicinal products. For administrative and judicial purposes a precise definition of "medicinal product" must be established in the national drugs legislation. This definition commonly reflects the usage for which the product is intended, e.g. "medicinal purpose" (see paragraph 5, p. 106).
In turn, "medicinal purpose" must be defined. Any such definition will refer to the treatment and prevention of disease, but - in order to include products such as contraceptives and anaesthetic drugs - the meaning is commonly extended in a more arbitrary sense to include diagnosis of a disease or a physiological condition, and modification of a physiological function.
Safe and effective use of a medicinal product depends not only upon its innate biological activity, but also upon the judgement, knowledge and qualifications of the person responsible for supplying, selling, prescribing, or administering it, and on the evaluation by the national drug regulatory authority. Products must be classified subject to international conventions concerning narcotics and psychotropic substances. Furthermore, each medicinal product should be classified according to whether it is:
(a) available only on the authority of a doctor, dentist or veterinary surgeon - prescription-only medicines; or
(b) available under the supervision of a pharmacist only from a registered pharmacy - pharmacy-only medicines; or
(c) available from retail outlets other than under the supervision of a pharmacist.
The terms of reference of a national drug regulatory authority are typically directed to regulation of the distribution, sale, supply and promotion of medicinal products, not to regulating the practice of medicine. However, decisions taken by the drug regulatory authority will no doubt influence prescribing behaviour and may contribute to rational use of drugs.
The drug legislation should include exemptions from the authorization/licensing provisions, for extemporaneous dispensing and small-scale production carried out by or with the order of appropriately qualified practitioners (pharmacists, physicians, veterinarians and registered practitioners of other named systems of medicine). Safeguards covering quality assurance and limits on quantities should be included. Special provision is included in many drug acts to regulate the range of medicinal products that practitioners other than registered practitioners are legitimately allowed to use. Such provisions have been developed in many countries for herbal products and homoeopathic products in particular.
Every regulatory authority faces the difficulty of determining whether particular "borderline" products are "medicinal products" within the meaning of the drug legislation. Tonics, food supplements, medicinal soaps and shampoos and other topical preparations for which medicinal therapeutic claims are made are examples of these products. Sufficient flexibility should be preserved in drafting the legislation to enable specific classes of products to be subject to or specifically excluded from the requirement for registration. The drug regulatory authority may be given statutory power to decide in borderline cases whether a product is medicinal or not.
Determining the scope of the marketing authorization will be strongly influenced by existing administrative arrangements. It is particularly important to recognize that a department of veterinary services or one dealing with traditional medicine practices may administratively oversee services without exercising regulatory control over the products used within the specific discipline. Before any decision to extend regulatory action to products relevant to these or other departments is contemplated, there is a need for interdepartmental consultation and coordination to determine any required legislative change, with a view to defining the products to be subjected to legal controls, the parameters of the proposed jurisdiction, the required regulatory powers and the associated responsibilities. The mechanics of exercising controls must be discussed and mutually agreed upon. There must be a clear demarcation of responsibilities and access to effective channels of communication. The administrative and technical competence of the ministries, departments, agencies or authorities must be respected at all times; issues of possible duplication or conflict of interest must be clarified as soon as possible.
Several legislative and administrative strategies exist to ensure closer and effective coordination between all concerned parties. Provision should be made, for instance, for prior consultation with such parties before the authority considers regulatory action. Representation of such interests on the authority itself is another possible option. The authority may even establish a sub-committee (e.g. a sub-committee on medical devices) with the mandate of assessing a particular type of product for regulatory action.
Availability of data
For the assessment of certain products, particularly those used in traditional medicine, often only limited data are available. When evaluating such products great care should therefore be exercised. The onus is on the applicant to provide the data required by the authority with respect to quality, safety, efficacy and registration status in other countries. Regulatory agencies may, however, require additional information about ingredients or the availability of similar medicinal products in other countries. Access to published sources of information is needed and authorities may also solicit the cooperation of drug regulatory authorities in other countries willing to share available data, subject to existing rules of confidentiality. WHO also has an important role to play in coordinating the supply of information from its own sources and through its information officers.
The revised WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce covers medicinal products both for human use and for use in food-producing animals. Experience to date suggests that its extension to cover a group of veterinary medicines has facilitated the work of authorities. The rationale underlying the Certification Scheme is equally applicable to all health-related products. By legislation, the concept of a certificate provided for by the existing scheme can be extended to cover all or selected health products.
In view of the technical nature of the work involved in the regulation of medicinal products, the drug regulatory authority should employ appropriately qualified scientific staff. In addition the authority should be able to enlist the assistance of professionals who might have specialist knowledge about some of these products. Through contact with other authorities, guidance can be obtained on technical issues which require more detailed expertise. For the purposes of marketing authorizations the legislation may provide for the recognition of a medicinal product which possesses a marketing authorization in a named state.
In an increasingly interdependent world, schemes of mutual support and cooperation will provide the basis for establishing systems to ensure the quality, safety and efficacy of as many health-related products as possible.