Following its re-elevation to a ministerial level, the Chinese drug regulatory body has rebranded itself the China Food and Drug Administration (CFDA).
Sale of medicines on trains and planes is just one reform being considered in a series of simplification measures aimed at increasing industry efficiency by the MHRA.
Health Canada says moving to an electronic filing system for regulatory submissions will reduce costs but warned drugmakers not to include their credit card details.
The US Environmental Protection Agency (EPA) says Teva still needs to address environmental issues at Missouri API plant landed with a $2.3m civil penalty.
Marketed drugs will not need to be tested under final guidelines on 'tablet scoring' for branded and generic medicines issued by the US Food and Drug Administration (FDA) this week.
Pfizer, GlaxoSmithKline, Roche and 26 other large pharmaceutical companies will provide about $5.85m (3.5m Euros) over three years to fund an Interpol initiative to combat pharmaceutical counterfeits and crime.
The EC should add the US and Japan to list of countries exempt from new API import laws and intensify talks with China and India to prevent shortages according to EFPIA.
The European Commission (EC) says timelines for new laws requiring that risky drugs are marked for extra safety monitoring take industry practicalities into account.
The US FDA’s ability to inspect facilities, trial sites, and deal with all but its most pressing priorities will be restricted by mandatory government spending cuts according to the Alliance for a Stronger FDA.
Pharmaceutical firms targeting the European market should expect drug review fees to increase by 2.6 per cent from April according to the European Medicines Agency (EMA).
Food industry controls do not ensure porcine trypsin is virus-free according to the EMA, which proposes testing procedures for drugmakers which use the reagent in a new consultation document.
Inspections in countries not expected to confirm API quality or seek exemption from new EU import regs “cannot be seen as a solution” to shortage concerns says the MHRA.
As many as 300 API manufacturing sites will need to be inspected to prevent drug shortages after new EU import regulations come into effect this summer according to pan-European group the Heads of Medicines Agency (HMA).
US API manufacturers are getting increasingly worried about the looming July 2 deadline to come into compliance with the EU’s new requirements for written GMP certification.
The US FDA says draft guidelines on risk-based immunogenicity testing of protein drugs will encourage the pharma industry to continue development efforts.
European API distributors may see costs increase if guidelines requiring quality systems and ‘management representatives’ at distribution points are adopted.
‘Long awaited’ draft guidelines on excipient risk assessments proposed by the European Commission (EC) have been welcomed by industry group IPEC Europe.
Drug Master File (DMF) completeness reviews required under GDUFA could take three months and should be sought before ANDA submission according to the US Food and Drug Administration (FDA).
The FDA and Health Canada recently opened for industry comment new guidance from the International Conference on Harmonisation on the photosafety testing of drug compounds.
In its third warning letter released this year for a foreign manufacturer, the FDA has warned Novo Nordisk for failing to follow procedures designed to prevent contamination. But the company downplayed the impact of the letter and said it won’t create...
The US Food and Drug Administration’s (FDA) release of a final rule on cGMP for combo products raises a number of questions as to how drug and device companies will tweak or overhaul their quality systems and which suppliers of products will need to comply,...
The US pharma industry in 2012 saw the lowest number of reported cargo thefts and the lowest average value per incident since the data collection began in 1996.
Clinical trial inspectors are being called on by the European Medicines Agency (EMA) to focus their efforts more on findings that are likely to impact the benefit-risk evaluation of a drug.
As the Food and Drug Administration (FDA) ramps up its inspections of foreign pharma manufacturers in an attempt to root out GMP inconsistencies and faulty processes, a recent warning letter to Taiwanese manufacturer Beanne Chemical may serve as an example...
The US Food and Drug Administration (FDA) has adopted a practical Q&A from the International Conference on Harmonisation (ICH) to help sponsors and CROs craft clinical study reports (CSRs), an expert says.
Danish companies that make, use, distribute or import APIs will need to register by March 1 or cease operations according to the Danish Health and Medicines Authority (DKMA).
The US Food and Drug Administration (FDA) has finalized a rule clarifying current good manufacturing practice (cGMP) requirements for single-entity and co-packaged drug-device combination products with few changes to its proposed rule from 2009.
The European Medicines Agency (EMA) is looking to integrate guidance from the International Conference on Harmonization (ICH) and US Food and Drug Administration (FDA) into the revisions of two annexes related to its process validation and good manufacturing...
The US wants exemption from new European Union import rules for active pharmaceutical ingredients (APIs) and says such status would cut manufacturers' admin and help prevent drug shortages.
Chinese API makers will have to tell the SFDA if they have a European GMP certificate as part of a wider industry investigation prompted by new EU import laws.
‘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 cost of proposed new tests designed to ensure levothyroxine tablet quality is a small price to pay for manufacturers to ensure patient safety says the UK MHRA.
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.
In-PharmaTechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from AstraZeneca and Roche.
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.
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.
