(1999; 168 pages) [Spanish]
Part A. Administration
1. There shall be established a drug regulatory authority which shall comprise pharmacists, physicians and others.
In order to discharge statutory functions and exercise statutory powers effectively, it is important that the office of the drug regulatory authority should be accorded high visibility within the official structure and be staffed by suitably qualified professionals. This includes not only the provision of attractive terms of employment and salary structures, but also access to effective and speedy channels of communication to those in authority, while safeguarding, at all times, the independence of the office. Under ideal circumstances, the person who functions as the officer of the drug regulatory authority [or the secretary of the board] should no longer be involved in drug procurement functions; but where this is not possible, because of staffing constraints, every precaution must be taken to ensure that the two functions of drug regulation and drug procurement are kept distinct and separate.
When appointing the officer(s) of the drug regulatory authority [or members of the board] and of the advisory committee, one issue which must be addressed is conflict of interest. It is important to ensure that regulatory responsibilities are discharged without fear or favour.
In relation to medicinal product regulation and procurement, it must be emphasized that such products should be considered a special category; appropriate administrative regulations, including tender or import procedures, must guarantee the independence of those entrusted with regulatory as well as procurement functions.
2. The functions of the drug regulatory authority shall, inter alia, be:
(a) to require all medicinal products manufactured in, imported into or exported from the country to conform to prescribed standards of quality, safety and efficacy, and that the personnel, premises and practices employed to manufacture, promote, procure, store, distribute and sell such products comply with defined codes of practice and other requirements;
(b) to require continued conformity of medicinal products to such standards until their delivery to the end-user;
(c) to require that medicinal products are imported, manufactured, exported, stocked, sold, distributed or otherwise dealt with by duly authorized persons;
(d) to grant, after due assessment, authorizations/licences for medicinal products, whether locally manufactured or imported, and whether destined for the national market or export;
(e) to cancel the authorization/registration of, or cause to be recalled from the market, medicinal products the continued use of which may be detrimental to public health;
(f) to maintain an inventory of provisionally authorized/registered medicinal products;
(g) to publish lists of provisionally authorized/registered medicinal products and of products with marketing authorizations from time to time, for public information;
(h) to ensure that dossiers for marketing authorization of medicinal products are kept up to date by the applicants and to approve alterations/changes thereto;
(i) to inspect and license/authorize all manufacturing premises, importing agents, wholesalers, distributors, hospital dispensaries, pharmacies and retail outlets;
(j) to sample, analyse and otherwise test finished medicinal products released into the distribution chain, to ensure their compliance with labelled specifications;
(k) to monitor the market for the presence of illegal/counterfeit medicinal products;
(l) to ensure that the promotion and marketing of medicinal products is in accordance with product information as approved by the drug regulatory authority;
(m) to approve the use of unregistered/unauthorized medicinal products for clinical trial purposes or for compassionate use and to regulate clinical trials on medicinal products;
(n) to disseminate information on medicinal products to the health professions in order to promote their rational use;
(o) to collect authorization/registration and application and renewal fees;
(p) to monitor and review the implementation of the legislation;
(q) to advise the minister on matters concerning control and authorization/registration of medicinal products;
(r) to amend the rules and regulations as deemed necessary to keep pace with time demand(s).
This section lists some of the more important functions of the drug regulatory authority. Additional functions can be added to this catalogue.
3. The drug regulatory authority shall appoint such other officers as may be necessary to assist it (or the board) to perform duties and to exercise powers under this Law. Such officers shall be known as "authorized officers".
For purposes of inspection, supervision and monitoring, the drug regulatory authority [or board] will need the assistance of other officers. The number and type of officers needed depend essentially on the profile of the pharmaceutical industry. However, it is important that the human resources needed to implement the Law are duly taken into consideration in the health resources planning process.
4. The minister shall, in consultation with the drug regulatory authority, appoint a medicinal products advisory committee to advise the drug regulatory authority on any general matter concerning the implementation of the technical aspects of the Law or with regard to any specific medicinal product.
It is envisaged that the committee will provide guidance on technical/scientific as well as administrative matters. As there are significant differences between countries in the availability of pharmacologists, medical practitioners and pharmacists who can be considered for appointment to a committee of this nature, the legislative scheme does not address issues such as composition, size, quorum, working procedures and other aspects. Committee members should be free from conflict of interest. These are matters to be regulated by way of regulations promulgated under the Law. The representative of the drug regulatory authority should be an ex-officio member; ideally, such an officer should serve as the secretary of the committee as well.