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India cuts stability data reqs for API firms seeking docs to ship to EU

30-Oct-2014 - India has relaxed stability data requirements for API manufacturers seeking “written confirmation of quality” certificates needed to ship to the EU.

Apps pathetic: Drug industry mobile techs underperforming

30-Oct-2014 - Hardly anybody downloads Big Pharma apps according to a new report that suggests drugmakers seeking greater mHealth engagement should ditch the product-focused model and seek expert help.

Auf Wiedersehen PET? India to ban plastic bottles for liquid drugs

29-Oct-2014 - India will ban PET packaging for liquid drug formulations for children, the elderly and women of reproductive age in November according to a Government statement.

Neuro experts call for drug name shake-up; manufacturers more cautious

28-Oct-2014 - Psychiatric drugs should be renamed according to their chemical make-up, not the symptoms they treat, according to leading neuropsychopharmacologists.

Superbug-driven surge in polymyxin demand prompts EMA to reassess safety info

27-Oct-2014 - A superbug-fuelled resurgence of polymyxin antibiotics has prompted the European Medicines Agency (EMA) to re-examine safety warnings for the side effect heavy anti-infectives

Lawyers question legality of US FDA final guidance on delaying, denying inspections

27-Oct-2014 - What may seem to be relatively minor changes between the FDA’s draft and final guidance on delaying, denying, limiting or refusing a facility inspection could actually be more major as two lawyers called the final guidance , “critically vague and legally questionable in several ways.”

Starting debate: EMA says rules on API materials need clarification

23-Oct-2014 - Drugmakers’ clashes with regulators over the suitability of API starting materials suggest ICH Q11 is open to interpretation and that clarification is needed according to the EMA.

EMA launches rolling review process for Ebola vaccine makers

23-Oct-2014 - Ebola vaccine developers can seek scientific guidance and approval through a rolling assessment system established by EMA to accelerate the process review.    

EMA tells us it looks forward to continuing close relationship with DG SANCO

Juncked: Plan to move EMA from DG Health to DG Enterprise is abandoned

22-Oct-2014 - DG Health will keep responsibility for the EMA according to European Commission President-elect Jean-Claude Juncker, who confirmed plans to hand the agency to DG Enterprise have been abandoned.

Global TB drug development efforts underfunded says WHO

22-Oct-2014 - Janssen-Cilag’s bedaquiline and Otsuka’s delamanid notwithstanding, the drug industry is not spending enough on the development of tuberculosis medicines according to the WHO.

Correction

Biotherapeutics need general chapters not individual Ph. Eur. monographs says EGA

21-Oct-2014 - Generic drugmakers want biotherapeutic products to have general recommendations in the European Pharmacopoeia rather than individual monographs.

NEWS FROM CPHI

The key to market exclusivity? Forget molecules, patent your tests

21-Oct-2014 - Makers of branded drugs are finding ways to extend their marketing authorisation by patenting not only molecules, but patient screening methods and ways of proving bioequivalence.

FDA to combine all of its quality ops under a new ‘super’ office

21-Oct-2014 - By early next year the US FDA is set to launch a new “super” office known as OPQ (Office of Pharmaceutical Quality), which will better align the review, inspection, and research of drugs.

Quality probs and rising wages will see new API hubs replace China and India says analyst

20-Oct-2014 - Analysts predicting a second wave of global API hubs say it will be hard for manufacturers in Latin America, Ukraine and Taiwan to avoid the pitfalls that stymied former high growth sectors in Asia.

Canada issues licenses for critical drugs hit by Apotex/IPCA import alert

20-Oct-2014 - Over forty “necessary products” made at Apotex and IPCA facilities hit with an import alert can be sold in Canada after regulators took steps to prevent shortages.

News from cphi

Big Pharmas and API suppliers eyeing Brazilian Government deals says EMS

16-Oct-2014 - Government contracts guaranteeing market share in Brazil are starting to attract innovators like Roche, Novartis and Sanofi and may see API suppliers get long-term work according to a spokesman for Sao Bernardo do Campo-based drugmaker, EMS.

news from the edqm 50th anniversary conference

Food supplements are Europe's real counterfeit drug problem says AIFA expert

15-Oct-2014 - Drug active ingredients in food supplements are Europe’s real falsified medicines problem according to the head of AIFA’s counterfeit prevention team.

Exclusive interview

Global regulators demanding needless drug quality levels, says Indian Gov

15-Oct-2014 - Overzealous and unnecessary quality demands by some regulatory agencies are driving up the cost of medicines, according to the Indian Government.

Free trade and strong IP held back Ebola vaccine development says NGO

15-Oct-2014 - The lack of an Ebola vaccine decades after the virus was discovered is due in part to IP protections in trade deals like TTIP that discourage innovation according to NGO, Health Action International (HAI).

News from edqm 50th anniversary conference

IPEC calls for inclusion of excipient compound monographs in Ph. Eur.

14-Oct-2014 - 'Excipient compound' monographs should be included in the European Pharmacopoeia according to IPEC, which argues they would help manufacturers and promote acceptance of the standards outside Europe.

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