Swiss Pharmacopoeia

Since 1865, the Swiss Pharmacopoeia has been a synonym for the quality, safety and uniformity of medicinal products. What started as a Latin recipe book for pharmacists is now, in combination with the European Pharmacopoeia, a mandatory reference work and cornerstone of Swiss medicinal product regulation.

A pharmacopoeia is an official rule book. It sets the mandatory quality standards that medicinal products have to fulfil to qualify as safe and effective. It defines standards for manufacture, control and authorisation, and is legally binding for all medicinal products placed on the market in Switzerland.

The Federal Constitution of 1848 laid the foundations for a pharmacopoeia for the whole of Switzerland, and the first Pharmacopoea Helvetica (Ph. Helv.) was published in Latin by the pharmacists’ association in 1865. Its aim was to ensure consistent quality in medicinal product manufacture in pharmacies.

The pharmacopoeia’s role changed with the arrival of industrialisation, when production shifted to pharmaceutical companies and the importance of state inspections increased. As a result it became mandatory for pharmacies, the industry and regulatory authorities and is now a legally enshrined compendium of quality specifications.

The foundation in Switzerland is provided by the European Pharmacopoeia (Ph. Eur.), supplemented by the Ph. Helv. This latter publication is used where European regulations do not cover areas specific to Switzerland, such as traditional preparations and herbal medicinal products such as standardised chamomile fluid extract.

In recent years, the Ph. Helv. has been further augmented. For example, it now includes specifications for the manufacture of medicinal products in small quantities. A note on the targeted reduction of mercury to protect human health and the environment was also added. The Ph. Helv. was digitalised in 2019, since when it has been publicly available at no charge. It has taken account of the changing legal framework by including rules for the production of radiopharmaceuticals, for example, and labelling requirements for formula-related medicinal products.

A monograph on cannabis buds was added to the Ph. Helv. to take account of current medical needs until such time as the Ph. Eur. included an equivalent monograph. The new 13th edition of the Ph. Helv. will be published during 2026.

The Ph. Helv. is constantly updated to reflect the current state of science and technology. Expert pharmacists and specialists from industry, the authorities and analytical laboratories are invited to actively make suggestions and drive forward the development of the pharmacopoeia. In Switzerland, it is Swissmedic’s responsibility to ensure that pharmacopoeia standards are defined, kept up-to-date and implemented in real-world practice.