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November 02, 2013
Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.
September 02, 2013
The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?
August 02, 2013
Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.
July 02, 2013
European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.
June 02, 2013
A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.
May 02, 2013
While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.
April 02, 2013
The European Union authorities are stepping up their efforts to incorporate quality-by-design principles into their regulations and guidelines.
March 02, 2013
Discussions are underway as the pharmaceutical sector calls for greater consistency in the global monitoring of GMP compliance and quality testing of APIs and finished medicines.
January 01, 2013
The EU fine-tunes legislation for the Falsified Medicines Directive, which is due to take effect this month as part of efforts to better protect patients from counterfeits.
November 02, 2012
The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on biosimilar monoclonal antibodies (mAbs).