Guaranteeing that drugs are safe, efficacious and manufactured and stored in accordance with quality standards is another goal of pharmaceutical policies. This can be achieved through regulation and control of registration, ingredients, production processes and the product itself.
Four types of action can achieve this based on approval of the use of active ingredients and their combinations [health registration], proof of cost-effectiveness and the cost earnings ratio of new drugs, control over production conditions and product surveillance.
Ensuring standards of efficacy, safety, quality and bioequivalency are important in protecting life and health and in stimulating price competition between manufacturers. Once efficacy, safety, quality and bioequivalency are assured, consumers can safely buy lower-priced medicines.
An initial regulatory strategy could be to require, as part of registration, bioequivalency studies for specific products and therapeutic priorities that require them. And in the case of new products to demand a cost-efficiency study to prove that the new drug or mixture is more effective and useful than existing treatments at a given cost.
A complementary measure would be to control the quality of imported ingredients and national production by periodic inspections carried out by the regulatory authority or with the help of specialized universities.
Production conditions, known as Good Manufacturing Practices, must be supervised as well, with forward-looking requirements on infrastructure investment, equipment, maintenance, training, quality control centres and control procedures. The regulatory authority should make periodic inspection visits to verify that recommended procedures have been adopted. The quality of products destined for the consumer should be checked by random sampling, optimization plans and an effective sanctions system. At the same time, the epidemiological impact of medicines should be studied and pharmacovigilance programmes established.