Pharmaceuticals Policy and Law - Volume 4, issue 0
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The new international review,
Pharmaceuticals Policy and Law, appears with the aim of studying and evaluating the
legal status of medicinal products in the European Union, and its implications in other markets such as the USA and Japan, without neglecting the specific problems of developing countries.
Pharmaceuticals Policy and Law intends to participate in the process of world convergence of pharmaceutical legislation helped by a network of academic centers specializing in pharmaceutical law, without omitting a scientific, economic and social approach to medicinal products.
The specificity of medicinal products conditions their legal status. Legislation regulating other goods cannot be applied to them. To begin with, they are the result of scientific and technical innovation. Research policies determine their progress. The pharmaceutical industry is, by nature, multinational. But, next to these global trends, different traditions still remain at a national level. Within the EU, barriers to free trade in medicinal products still remain despite more than thirty years of harmonisation. The social dimension of medicinal products is complex and very significant in the preoccupations of our societies. Patenting is essential but not sufficient. The life-cycle of medicinal products is protected by professional responsibility, required in the general concept of health safety. It is important to remember their ethical dimension, including research and innovation in new fields such as genetic manipulation and biotechnology, which requires social consent to preserve human dignity and fundamental rights.
Abstract: The design of a database of medicinal products presents conceptual questions for which there is not a unique answer. The reason for this is that medicinal products relate to the procedures for marketing authorisation and regulatory practice has diverged between regions and organisations. Some of these issues refer to the definition of medicinal products; the relationship between types of pharmaceutical forms and the format of the strength; the definition of pack size; the relationship between strength…and pack size. This paper describes the way in which these aspects have been addressed within the IMP project, but without pretending to be a definitive solution. The EMP medicinal product database and the ELS tracking system for licensing, developed within the IMP project funded by the IDA Programme, are used by the European Commission in support to marketing authorisation of centralised medicinal products. Aspects not covered here include the relationship between products and markets, the implications derived from the change of proprietary names, and the relation between therapeutic indications and products.
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Abstract: A pharmacovigilance system is based on exhaustive and high quality information, in the first place information about adverse drug reactions. The paper describes the issues related to the implementation and use of MedDRA in pharmacovigilance systems.
Abstract: The present situation with respect to the use and acceptance of electronic submissions for marketing applications for medicinal products in the United States, Europe and Japan is presented. The activities of the International Conference on Harmonisation (ICH) towards a global standard for electronic submissions are described and the expected impact for the regulatory agencies and the pharmaceutical industry of such a global standard is reviewed.
Abstract: The EMEA, in collaboration with Competent Authorities of Member States and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA), initiated a joint pilot for the electronic transmission of individual case safety reports (ICSRs) in pharmacovigilance at the end of 1999. The rapid and secure exchange of pharmacovigilance information is of utmost importance to guarantee the protection of public health within the European Union (EU). The implementation…and testing of the specifications for the electronic exchange of ICSRs in line with the recommendations of the International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the joint pilot plan, adopted by the Committee for Proprietary Medicinal Products (CPMP) in August 1999, is therefore a new challenge in managing pharmacovigilance data more efficiently. The joint pilot objectives, the procedures and the results achieved within the first six months of these pilot activities are presented.
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