Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Article 58 Applications - Best Access to Drugs in Developing Countries? ***

Yuan Chen (Abschlußjahr: 2015)

Summary
Language: English
People in developing countries are not always privileged to have access to the best possible medicinal products. This can have different reasons. On the one hand, there are still many tropical diseases for which no drugs are available as pharmaceutical companies rarely concentrate on their research and development. On the other hand, authorities in low-income countries do not often have the regulatory capacity for a comprehensive and appropriate assessment of the technical documentation.
In order to improve this situation, Article 58 of Regulation (EC) 726/2004 allows the EMA, in collaboration with the WHO, to evaluate medicines which are intended exclusively for non-EU markets. This so-called Article 58 procedure follows almost the same principles as the Centralised Procedure, meaning that the scientific assessment is conducted within 210 days by the CHMP and that identical standards apply as for centrally approved products. However, the evaluation is specifically tailored to the particular needs of developing countries and therefore, experts from the target countries may also attend the plenary meetings as observers. But in contrast to the Centralised Procedure, it is completed with the adoption of a scientific opinion. A decision-making process is not included. Actual marketing authorisations are granted by local authorities in separate approval procedures.
Although the Article 58 procedure was already introduced in 2004, only 9 applications have been submitted since then. This can be explained by the low awareness level, but also by the requested fees which are very high compared to the alternative programmes offered by the WHO or the FDA. Despite its rare usage, the Article 58 is a step towards a better access to drugs in developing countries. It is to be hoped for the future that more pharmaceutical companies become aware of it and of the importance of medicines for neglected diseases.
Pages: 56, Annexes: 5, Pages: 71