EU prescription for clearing drugs faces challenge
- European Union Moves Forward with GMP Harmonization. Milmo, Sean // Chemical Market Reporter;01/29/2001, Vol. 259 Issue 5, pFR8
Reports on the European Union (EU) legislation for good manufacturing practice (GMP) standards in the production of active pharmaceutical ingredients (API). Documents finalized by the International Conference on Harmonization (ICH) that would harmonize technical standards for pharmaceuticals...
- How can we regulate medicines better? Garattini, Silvio; Bertele', Vittorio // BMJ: British Medical Journal (International Edition);10/20/2007, Vol. 335 Issue 7624, p803
The article presents the authors' opinions on how medicines can be better regulated in countries in the European Union. Arguments are presented which suggest that in order for medicine to be better regulated, the role of the European Medicines Agency (EMAE) plays in regulating medicine must...
- Opening up Europe. O'Donnell, Peter // Applied Clinical Trials;Feb2000, Vol. 9 Issue 2, p22
Examines the impact and benefits of the enlargement of European Union (EU) to include former communist countries of Central and Eastern Europe (CEE) to the pharmaceutical industry. Industry's concern over the way EU enlargement is process; Opportunities of the EU enlargement to the industry, as...
- From regulations to drug delivery... Mulligan, Thomas // Life Science Today;Apr2000, Vol. 1 Issue 2, p1
Editorial. Discusses the regulatory requirements imposed by the European Union on the pharmaceutical industry. Articles on process engineering; Development of drug delivery methods; Collaborations between academia and the industry.
- Eastern European Pharma Sector to Face Mixed Results Following Its Entry Into the EU. Milano, Sean // Chemical Market Reporter;6/23/2003, Vol. 263 Issue 25, p6
Reports on the outcomes of the entry of Eastern European manufacturers of pharmaceuticals and related intermediaries into the European Union. Factors affecting the entry of Eastern European pharmaceutical manufacturers; Impact on Western European counterparts; Discussion on the regulations of...
- The EU's Falsified Medicines Directive and APIs. // Pharmaceutical Technology Europe;Feb2013, Vol. 25 Issue 2, p50
The article presents questions and answers related to the impact of the Falsified Medicines Directive on the production of active pharmaceutical ingredients in the European Union.
- A sometimes unhealthy coalition. Iheanacho, Ike // BMJ: British Medical Journal (Overseas & Retired Doctors Edition;5/22/2010, Vol. 340 Issue 7756, p1144
The author reflects on the coalition between pharmaceutical industry and drug regulators in the European Union (EU).
- EU pharmacovigilance fees explained by EMA. // Reactions Weekly;Mar2015, Vol. 1544 Issue 1, p3
The article reports that the European Medicines Agency (EMA) has published an explanation of fees payable to the EMA for monitoring the safety of drugs that have been authorised in the EU. It describes types of fees, and fee exemptions.
- Bittersweet pills. Wylot, Robert // Warsaw Business Journal;12/10/2001, Vol. 7 Issue 50, p1
Examines the implications of the planned European Union (EU) membership of Poland to the pharmaceuticals industry. Merits of the planned EU membership; Expansion of Western European drug makers in the country; Reform of the public health care system.