As questions continue to be raised over the policies governing clinical trials in India, new regulations and amendments to the country's pharmaceutical laws are now coming to light.
The EU’s CHMP(Committee for Medicinal Products for Human Use) will delay the application of a guideline that would set limits on metal catalysts or metal reagent residues until the ICH finalizes its own guideline on the issue.
Chinese Police say GSK China rather than individual salespeople organised alleged bribery of doctors that is currently being investigated by the country's authorities.
The US FDA and EMA still disagree on some aspects of QbD, but collaborations like their recent pilot scheme can only be a good thing for industry according to a former MHRA assessor.
The US FDA has released a Q&A to offer more clarity to GPhA, Cipla, Akorn and other drug and API manufacturers who responded to the initial stability draft guidance for ANDAs.
Aoxing Pharmaceuticals reported increased sales and lower operating expenses for Q2 2013 one year on from the chromatin-tainted gelatin scandal that led to suspension of sales by China’s regulators.
Description of the manufacturing process in regulatory submissions must be the same whether the applicants use Quality by Design (QbD) or the traditional approach, the FDA and EMA have concluded.
The MHRA says it will assess the quality of active pharmaceutical ingredients (APIs) imported from outside the EU at manufacturers’ facilities rather than at UK borders.
The two-year pilot project will help the US Food and Drug Administration further assess the growing number of companies and countries involved in importing drugs to the US.
The US FDA has finalized guidance on clinical trial oversight, calling for more remote and targeted risk-based monitoring, though some experts believe such monitoring should be more judiciously employed.
US and foreign generic drug manufacturers will see a more than $40,000 increase in US FDA facility fees for 2014, while API manufacturers will see a more than $8,000 increase.
The Supreme Court of India late last week ordered all state government health secretaries to meet with the national Secretary of the Ministry of Health to discuss ways to strengthen the framework for regulating clinical trials.
EMD Millipore says while voluntary excipient quality schemes are step in the right direction, formal GMP and enforcement would create a level playing field.
Building on similar European documents, Australia’s TGA (Therapeutic Goods Administration) released guidance Tuesday to help assist drugmakers looking to win approval for their biosimilars.
The US FDA has amended the list of draft guidance documents it expects to release for the rest of the year with two new guidance topics, one deleted guidance and a few other hotly-anticipated documents still to come.
NovaMedica and the Russian Government are to build an $85m (€64m) facility as part of a joint venture encouraging local manufacturing, the company says.
Industry bodies say they support the sharing of trial data following allegations yesterday they used patient groups to lobby new EU transparency regulations.
The US FDA has sent Wockhardt a warning letter for its manufacturing plant in Waluj, India just days after UK authorities issued the site with a certificate of non-compliance.
US CBO claims that proposed track and trace legislation will not be too expensive for drugmakers already used to similar laws in California are ‘misguided’ according to an industry consultant.
Chinese understanding of European CEPs is good, but some manufacturers are still unclear on the related obligations and requirements according to auditing firm, blue inspection body.
Molecular Profiles has received the regulatory thumbs up on a second manufacturing facility and says it can offer its clients a breadth of services uncommon for CMOs.
The FDA has proposed a rule to allow its inspectors to detain adulterated or misbranded drugs found during an inspection for a short period of time and until the appropriate action is undertaken.
Simple steps to secure Rwanda’s pharma supply chain may serve as an example for other larger African countries looking to curtail the spread of falsified or substandard drugs, experts say.
Rebuilding 'problem' sterile manufacturing plants to modern specifications may be a better option than spending money trying to fix them according to an ex-GSK expert.
Wockhardt remains confident its troubled manufacturing facility in India will be back up and running in three months after receiving a certificate of non-compliance from the MHRA.
Chinese oversight of API plants is improving, but it is still important EU importers choose their sources carefully says European Medicines Agency (EMA) collaboration chief, Emer Cooke.
Drugmakers struggling with new EU API import rules now have details of the risk assessments that could solve their problems thanks to the Heads of Medicines Agencies (HMA).
Despite recent progress, the EC underestimated the challenge of getting non-EU regulators to ensure APIs shipped to the European Union (EU) meet new import requirements according to Eucope.
India’s top drug regulator is calling on manufacturers that received unauthorized drug approvals and manufacturing licenses to prove the safety and efficacy of their marketed drugs by August 31.
The EMA says new import laws and international collaboration means European drugmakers can now rely on the quality of APIs made outside the European Union.
The parallel QbD (Quality by Design) application review program by the US FDA and EMA is slowly revealing the differences between the two agencies but will never result in identical assessments or outcomes, experts said.
In a momentous first for both countries, regulatory officials from China and Taiwan sat down at the same table on Tuesday and discussed their relatively similar ideas around the regulation of drug approvals.
Europe could face drug shortages if the US is not granted exemption from new API import requirements, according to a US chemical industry trade association.
