Medicinal product manufacture

A medicinal product is a product used to treat diseases and medical problems in humans or animals. It can cure (curative medicine), relieve (palliative medicine) or prevent (preventive medicine) diseases. A medicinal product can replace substances or fluids produced by the body. It can also render harmless microbes, parasites and other foreign matter capable of causing a disease. Medicinal products consist of active substances that cause an effect or reaction in the body, and excipients that enable the product to be formed into tablets or drops, for example.

The long process of manufacturing a medicine

In its search for new active substances, the pharmaceutical industry draws on findings from basic research performed primarily at universities and other institutions of tertiary education. Numerous substances are tested in the pharmaceutical industry’s research laboratories in various phases – in preclinical studies and clinical trials – and in a specific, predefined context for efficacy and safety in animals and humans. Genuine breakthroughs are relatively rare in medicine, despite the major effort that goes into research. Smaller advances resulting from the continuing development of known active substances are more common. But for patients, these small steps forward are just as important. This is particularly evident if we think of examples such as insulin therapy for people with diabetes, therapy for asthma sufferers, transplantation medicine and cancer therapy. If no therapeutic alternatives were available, many patients would have to make the best of treatment that was less than ideal for them. These small improvements include greater efficacy or improved safety as a result of fewer side effects. They can be achieved by optimising active substances or developing new dosage forms tailored to patients’ specific needs.

The pharmaceutical industry makes the investment and takes the risk

There is a high risk that development of a medicinal product will be stopped because of adverse effects or insufficient efficacy discovered in the course of clinical trials. Just 10 out of every 10,000 substances that are investigated and tested in the research laboratories make it as far as clinical trials. And just one of these substances passes all the clinical tests and subsequently comes onto the market as a medicine. Nowadays the costs associated with developing an innovative medicinal product exceed CHF 1 billion. The Swiss pharmaceutical industry finances its research activities completely from its own resources, and thus bears the entire risk associated with research. Research-based companies need an assurance that their discoveries will not be exploited economically by third parties who have not shared in the high cost of researching these products. The state protects companies by granting a limited period of patent protection for a new active substance.

Manufacture of medicinal products

The manufacture of a medicinal product begins with the isolation of the active substance, which is then processed into a specific delivery form, such as tablets or ointment, with the aid of excipients. Finally, the medicinal product is filled by machine into specially designed packaging. Medicinal products are manufactured in batches. Quality control and quality assurance measures ensure that only medicinal products of flawless quality come onto the market. If a batch is found to be faulty, the product can be recalled using the batch number. It is vital for the consumer that medicinal products are safe to use. The manufacture of these products is therefore subject to strict regulatory controls. In Switzerland this is the responsibility of Swissmedic, with the involvement of the cantons.

The manufacture of medicinal products is governed by the international standards of Good Manufacturing Practice (GMP) specified in Annex 1 of the Medicinal Products Licensing Ordinance (MPLO) adopted by the Federal Council. The GMP-compliant manufacture of medicinal products is also important for the recognition abroad of products manufactured in Switzerland.