‘Unfair competition’ from Asian drugmakers and the prevalence of counterfeits are among the challenges facing African manufacturers according to a new pan-African industry group set on fostering local production.
The UK's cell therapy industry now has a database of all ongoing clinical trials in the country with the aim of expanding research partnerships and pushing more early-stage trials to later stages.
GlaxoSmithKline has decided to only make once-monthly payments to suppliers, which could increase the amount of time it takes a CRO, CMO or other supplier to be paid for its work.
The European Commission has updated its GMP guidance to notify manufacturing authorization holders (MAHs) of their legal obligation to ensure that active substances are produced in accordance with GMP.
The European Union is now recognizing GMP inspections in both Israel and New Zealand, which should lead to less delay in bringing drugs to market and fewer inspections in all three areas.
Indian drug manufacturers have 18 months to test drugs not approved by India’s Central Drugs Standard Control Organization (CDSCO) for efficacy and safety or they will be pulled from the market.
Foreign generic drug and API manufacturers will have to pay $15,000 more than their US counterparts because of additional costs required for the US Food and Drug Administration (FDA) to inspect the overseas facilities.
Indian pharmaceutical exporters now need to apply barcodes on their secondary packages as part of an effort to increase safety and traceability, but some have avoided the requirements, experts say.
In-PharmaTechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from AstraZeneca and Roche.
EU pharmaceutical and active substance manufacturers should determine the threshold for cross-contamination when multiple drugs are produced in shared facilities.
The drug industry is seeking more clarity on the descriptions of variations made to marketed drugs under the European Commission’s regulation governing the ways marketing authorizations can be re-classified.
The US Food and Drug Administration (FDA) can require opioid generics to have abuse-deterrent properties if the same requirements are applicable to their brand name counterparts, FDA Commissioner Margaret Hamburg said in a letter to Rep. Fred Upton (R-Mich.)...
The UK MHRA says regulators Europe-wide are asking drugmakers for additional data to identify plants that need to be inspected under new EU API import rules.
United Parcel Service (UPS) has abandoned its bid to buy Holland-based logistics firm TNT Express after the European Commission said it would block the deal.
The Indian Pharmacopoeia Commission (IPC) says a first of its kind guidance manual will help drugmakers comply with quality requirements and testing procedures.
An advocacy group says actor Jack Klugman's support was key for US law that encouraged pharmaceutical firms to make drugs for rare diseases over the past 30 years.
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The MHRA says as many as 1,200 active pharmaceutical ingredient (API) manufacturing plants may need to be inspected to secure UK supply chains when new EU import laws come into effect next year.
Drugmaker Pfizer is on the list of 74 firms that have not paid their share of the $50m ‘backlog’ fee required under the Generic Drug User Fee Amendments (GDUFA) law.
Chemi Pharmaceutical CEO says sabotage by former employee behind accusations of falsified test results that prompted Canadian regulators to suspend license.
GE Healthcare says new cell science lab in Wales will save drugmakers time and money and create more accurate alternatives to animal-based drug toxicity testing models.
Positron emission tomography (PET) drug manufacturers have three years to gain NDA or ANDA approval or they must remove their products from the market according to the US FDA.
The group whose comments on sponsor oversight drew criticism from ACRO says the industry group's preferred ‘trust and verify’ model only works if verification efforts are robust.
Ranbaxy has predicted ‘market disruption’ after quality problems forced it to halt production of its generic version of Pfizer’s cholesterol buster Lipitor.
in-PharmaTechnologist.com presents its latest round-up of movers and shakers in the world of pharmaceuticals, including news from Cipla, Dr. Reddy’s and Immunogen.
The USP has delayed new elemental impurities standards but is still confident they can be harmonized with ICH Q3D even if May 2014 implementation target is kept.
Euticals Limited has halted API production at its Welsh site after local authorities found it was housing “substantial” quantities of a potentially explosive chemical.
