News in Brief
European pharmaceutical companies Hoffmann-La Roche, BASF and Rhone-Poulenc are being supported by the International Chamber of Commerce in a US Supreme Court case that could make US courts de facto global anti-trust regulators, even in cases with a negligible US impact. They want justices to overturn a DC Court of Appeals ruling allowing non-US plaintiffs to bring foreign anti-trust claims to American courts. Ecuador's Empagran brought the lawsuit claiming damages caused by alleged vitamin price fixing.
Reforms to EU drug precursor legislation have been approved by the European Parliament and the EU Council of Ministers. They strengthen controls on two key substances - potassium permanganate and acetic anhydride - used to produce cocaine and heroin. Also, all precursor movements within the EU will henceforth need to be accompanied by customer declarations. Non-EU imports and exports are covered by separate regulations.
The EU Council of Ministers has approved a string of reforms to EU pharmaceutical legislation, designed to boost research, innovation and the working of the internal market while protecting patients. They include a new regulation on authorising and supervising medicines (and on EMEA); directives on EU codes on human and veterinary medicines and a directive on traditional herbal medicines.
EMEA has released updated guidelines on the use of plastic primary packaging materials in the pharmaceutical industry (www.emea.eu.int/pdfs/human/qwp/435903en.pdf), as well as on stability testing for medicines manufactured in hot countries outside the EU, classified by Brussels as climatic zones III and IV, (www.emea.eu.int/pdfs/human/qwp/614203en.pdf).
Guidance on the parallel distribution of authorised medicinal products in the EU is being drawn up by EMEA. The agency is keen to streamline authorisations for parallel imports within the EU and clarify relevant rules.
Guidelines on requirements for vaccine antigen master file certification have been released by EMEA, (www.emea.eu.int/pdfs/human/bwp/454803en.pdf), as well as guidelines on the scientific data requirements for a vaccine antigen master file (www.emea.eu.int/pdfs/human/bwp/373403en.pdf). Meanwhile, the agency has released guidelines on recording core data for herbal medicinal substances and preparations (www.emea.eu.int/pdfs/human/hmpwp/004101en.pdf).