The US FDA has finally adopted the revised ICH Q11 guidelines on drug substance manufacturing nearly six months after European regulators embraced the guidelines.
Domestic regulatory efforts to improve ingredient quality will increase costs but Indian industry will remain competitive, according to the Secretary of Commerce.
An industry consortium has asked the USP to delay new elemental impurities chapters on concerns that lack of harmonization with ICH Q3D will create compliance difficulties, shortages and additional costs.
Barack Obama’s re-election will mean millions more US citizens have health insurance, which has significant implications for the pharmaceutical industry.
Pharmaceutical firms should let the EMA know about minor variations to marketing authorisation (MA) by the end of next month if they want to avoid delays over the festive period.
The UK Intellectual Property Office (IPO) wants to make it easier to develop drugs in the country by changing the rules relating to patent infringement in clinical trials.
Watson and acquisition target Actavis must sell 18 drugs to rivals Sandoz and Par Pharma under conditions imposed by the US Federal Trade Commission (FTC).
Manufacturers trying to prove the similarity of their biosimilars must consider that regulations and reference medicines differ in different markets says Pfizer.
Stricter GMP requirements in Peru are increasing the time it takes to get drugs approved and may not be giving regulators any useful additional information.
in-Pharmatechnologist.com is going to Madrid, Spain to meet API and excipient makers, Biopharma firms, processing tech developers and contract services organisation gathered for one of the drug industry's biggest trade shows.
Drugmakers in Pakistan are suffering and parliament needs to implement on the proposed Drug Regulatory Authority (DRA) according to the Pakistan Pharmaceutical Manufacturers Association (PPMA).
Fercy Personal Care Products received an FDA warning letter after quality staff handed inspectors just two pages from a notebook as ingredient records.
Proposed EMA pharmacovigilance fees are too high and place a disproportionate burden on generics firms according to the European Generic Medicines Association (EGA).
Lundbeck has decided to stop making a cancer drug deeming the cost of securing API supplies too big and the likelihood to regulatory acceptance too small.