The purpose of the Law on Therapeutic Products is to ensure that products placed on the market are of high quality, safe and effective.
In Switzerland, the Pharmacopoeia consists of the European Pharmacopoeia (Pharmacopoeia Europaea, Ph. Eur.) and the Swiss Pharmacopoeia (Pharmacopoeia Helvetica, Ph. Helv.). It is published by Swissmedic as prescribed by the Law on Therapeutic Products and contains risk oriented prescriptions relating to the quality of medicinal products and pharmaceutical excipients that are known and in use and certain medical devices. The prescriptions are drawn up in line with the latest status of scientific and technical knowledge. They are binding and constitute legislation. The Pharmacopoeia thus makes a considerable contribution towards ensuring that therapeutic products of equally high quality are available to patients, and creates a central prerequisite for safe, effective therapeutic products
The texts of the prescriptions in the Ph.Helv. complete those of the Ph.Eur. in cases where there is a recognised need for quality prescriptions that are applicable throughout Switzerland but where there are no corresponding texts in the Ph.Eur. The drafting and enactment of the Ph.Helv. are carried out taking legal prescriptions into account, and are based on the three following pillars: "Structure", "Process" and "Content".
- The Pharmacopoeia Division co-ordinates a network of experts, and has various specialised committees (Expert Committees), which provide support and advice to Swissmedic for drafting and enacting the Pharmacopoeia (Ph. Eur. and Ph. Helv.). This structure makes it possible to take the latest scientific findings and the requirements of pharmaceutical practice into account in an institutionalised way.
- Predefined work procedures ensure a systematic approach to work on drafting Pharmacopoeia texts and for the enactment of the Pharmacopoeia according to the legal requirements.
- Decisions regarding the content of the Ph. Helv. are taken in a transparent and comprehensible way, in line with the content of the Ph. Eur. They are based on defined criteria concerning the inclusion, modification and deletion of Pharmacopoeia texts.
- The quality-related prescriptions in the pharmacopoeia take into consideration risks related to the safe use of therapeutic products and are drawn up on the basis of the corresponding requirements, which are founded on internationally recognised practice.
The mission of the Swiss Pharmacopoeia states the purpose of the Ph. Helv. and describes the principles for its drafting and enactment. Additional quality assurance elements, working tools to provide support, and concrete projects are based on the principles described in the mission.
The availability of safe, effective therapeutic products requires the products concerned to be manufactured and tested at the necessary level of quality. The Law on Therapeutic Products1 therefore requires that only high quality, safe and effective therapeutic products are placed on the market2 and stipulates that Swissmedic is responsible for enacting the Pharmacopoeia. The Pharmacopoeia is defined as a compendium of prescriptions regarding the quality of medicines, pharmaceutical excipients and certain medical devices and for which compliance is mandatory in order to place medicinal products and pharmaceutical excipients on the market3.
The legally binding prescriptions in the Pharmacopoeia (Ph. Helv. und Ph. Eur.) permit all patients to have therapeutic products available that are of equally high quality, since this is a prerequisite for safe, effective treatment. Particular emphasis here is placed on commonly used, known medicinal products or pharmaceutical excipients.
In accordance with the legal mandate, the Ph. Helv. serves as a national supplement to the prescriptions of the Ph. Eur., which are valid in Switzerland on the basis of a relevant treaty. In this way, existing needs for the quality requirements valid throughout Switzerland can be met. This is of particular importance for medicinal products that are only available on the Swiss market and for those that not require a Marketing Authorization and are manufactured by retailers and dispensed to their own clientele.
The methods and the monographs of the Ph. Helv. can, if needed, also serve as a model for drafting European prescriptions. If any text is included in the Ph. Eur. it is deleted from the Ph. Helv.
Fulfilling the legal mandate means that the framework conditions stated in the Pharmacopoeia Ordinance4 must be respected. To ensure that this is the case, the drafting and enactment of the Pharmacopoeia is based on three fundamental pillars: "Structure", "Process" and "Content".
The creation of specialised committees in various areas (Expert Committees) makes institutionalised and thus lasting collaboration between Swissmedic and the various groups of users possible ("Structure"). The experts in the committees, from various sectors such as the authorities, graduate institutes, industry, dispensing pharmacies and hospital pharmacies, make it possible to pay the legally required attention to the latest scientific findings5. By bringing in various groups of users as early as the drafting stage of the Pharmacopoeia, the users' needs, i.e. the needs of pharmaceutical practice6, are taken in to account as is also legally required.
Drawing up the work procedures and providing transparent descriptions thereof ("Procedures") results in the systematic and thus targeted process of drafting Pharmacopoeia texts and enacting the Pharmacopoeia.
Defining criteria for including, modifying and deleting Pharmacopoeia texts and the requirements for drafting them ("Content") ensures that the resources available are used in a targeted and beneficial way, and that the risks to be taken into account for a safe use of therapeutic products are adequately addressed by the quality requirements stated in the Pharmacopoeia.
Consequently, when drafting the Ph. Helv., emphasis is placed on prescriptions relating to medicinal products and pharmaceutical excipients that are commonly used and known in Switzerland and thus that are generally considered to be appropriate and those for which there is a recognised need. This means, in particular,
- Substances contained in medicinal products and that have been approved within the framework of an official authorisation process, and
- Preparations that contain known substances and that have long proved their therapeutic value in the form concerned, but that are not, or no longer, available as authorised medicinal products
1Law on Therapeutic Products, LTP; SR 812.21
2Art. 1, para. 2, LTP
3Art. 4, para. 1, letter g) and Art. 52, LTP
4Pharmacopoeia Ordinance, PhaV; SR 812.211
5Art. 52, para. 2 LTP and Art. 2, para. 1, PhaV
6Art. 52, para. 2 LTP and Art. 2, para. 1, PhaV