IHS Global Insight Perspective | |
Significance | The AEMPS presented last week the fourth edition of the Royal Spanish Pharmacopoeia, setting up the standards for drugs in the country. |
Implications | The new edition updates the requirements of around 2,200 compounds, including a specific monograph in each category. |
Outlook | The edition is part of the agreement subscribed in 2008 with EDQM, aiming to harmonise the pharmacopoeia requirements in an international context. |
The Spanish Agency for Medicines and Health Products (AEMPS) presented last week to the Ministry of Health, Social Policy and Equality (MSPS) the fourth edition of the Royal Spanish Pharmacopoeia. The presentation was opened by the Director of the Agency, Belén Crespo, and closed by the general secretary of Health, José Martínez Olmos. As it is stated in the law of guarantees and rational use of medicines and medical devices, the Royal Spanish Pharmacopoeia (RFE) is the code that sets the quality that active pharmaceutical ingredients must meet in the composition of drugs for human and veterinary use. In addition, according to the Spanish legislation is the reference code for all areas and stakeholders related to drugs, such as health authorities, universities, the Royal Academy of Pharmacy, hospitals and pharmacies, and the pharmaceutical industry.
Quality of Drugs
The presentation highlighted that the Royal Spanish Pharmacopoeia provides accessibility in Spanish language to the most prestigious legal compendium in the international context, in terms of quality of medicines and it is a tool that will help to minimise the risks of drugs and other pharmaceutical substances in relation to the assessment, control and inspection of their quality. During the presentation, Benito del Castillo, chairman of the Committee of the RFE, has developed a lecture on the Royal Pharmacopoeia, and the secretary of the RFE, Carmen de la Morena, presented the Pharmacopoeia online format, available using information technology resources, for all stakeholders through a subscription providing access to the work throughout the term of the fourth edition.
The Royal Spanish Pharmacopoeia consists of some 3,550 texts, including specific monographs on active substances, general monographs on drug classes, dosage forms monographs covering all preparations included in the scope of each category required and general methods to carry out mandatory checks which are described in analytical specific monographs. It also describes the requirements of some 2,200 chemical compounds. The specifications defined in the monographs are requirements that are mandatory and minimum. In fact, every molecule presented in a scientific or common name within the Pharmacopoeia has to meet the specifications written on it.
Outlook and Implications
In 2008, the Competent Authority signed a memorandum of co-operation with the European Directorate for the Quality of Medicines & HealthCare (EDQM) for the publication of the Spanish version of the European Pharmacopoeia, after review and validation of the texts by the Competent Authority. Thus, the objective of the agreement was to prevent the gap between the publication of the European Pharmacopoeia and the Royal Spanish Pharmacopoeia, increasing the role of the latter, with considerable benefit for the Spanish users. The fourth edition is meeting the objectives of continuity and constant updating, integrating the sixth edition of the European Pharmacopoeia and achieving international harmonisation amongst different Pharmacopoeias, such as from Japan and Europe.