Moving forward, China will take a more integral role in global drug development, following several regulatory changes designed to accelerate innovation.
Sandoz is the latest Zhejiang Huahai Pharmaceutical customer to issue a nationwide recall after trace amounts of a probable carcinogen were found in the supplier’s API.
Jiangsu Yew Pharmaceutical outright refused permission for inspectors from Hungary to visit its site, resulting in the suspension of the company’s marketing authorisation.
Chongqing FDA has published an open letter, apparently from an employee of Fosun Pharma, stating that the firm has fabricated a “large number” of production reports.
The latest regulatory update in the valsartan recall saga comes from the US FDA, which has published Form 483s relating to inspections at Zhejiang Huahai plants in 2016 and 2017.
The Chinese government has released a notice telling medical institutes to comply with the recall of products containing contaminated valsartan and stop using the medicine.
By Doug Peddicord, PhD, executive director of the Association of Clinical Research Organizations (ACRO)
As the great Yogi Berra once said, “It’s tough to make predictions, especially about the future.” But it is safe to say that after a year of considerable consolidation and change, the CRO industry anticipates continuing and potentially rapid evolution...
The Chinese pharmaceutical industry sets a positive outlook for regulatory harmonization as its Marketing Authorization Holder pilot program progresses.
Flamma has opened a new cGMP workshop and R&D Center in Dalian, China and is looking to add capacity at several other sites as part of its “Flamma 2020 plan.”
GSK’s HIV unit ViiV Healthcare and China-based Desano Pharmaceuticals have forged an agreement whereby Desano will manufacture the API of GSK’s HIV drug Tivicay (dolutegravir) in China.
Sydney-based contract research organization Novotech has expanded its Hong Kong operations with a new permanent office and prospects for four more staffers to meet the increasing demand in the research market.
Charles River Labs (CRL) has singled out China as an area of “disproportionate growth” in biologics R&D and says it is on the hunt for preclinical acquisitions in the region.
Pharmaceutical companies are rushing to respond to shortened deadlines from China’s Food and Drug Administration (CFDA) for serialising drug packaging.
Experts have predicted emerging Indian and Chinese markets will outpace Western markets as the $2.3bn oral solid dosage form (OSDF) excipients global market grows at a sustainable rate.
Inspecting the thousands of Chinese factories making APIs for the US market is a “hopeless task” even if the FDA gets the extra staff it wants according to a Congressional committee review.
Actavis has announced plans to sell its stake in its Chinese subsidiary just days after telling investors the country is 'too risky' for new investments.
The US FDA told us that China has “taken longer than FDA had hoped” in approving the visas of new FDA inspectors that would more than double the agency's presence in China.
West has begun production at its second manufacturing facility in China, driven by the growing market for pharma injectable components in the Asia pacific region.
With the Chinese NAP (nucleic acid purification) market expected to grow more than 8% over the next year and no clear market leaders, companies are looking to take control of the industry space.
Boehringer Ingelheim will build a biomanufacturing facility in Shanghai in a strategic alliance designed to cater for Pharmas nervous about setting up plants in China.
The International Pharmaceutical Excipients Council (IPEC) Americas has welcomed new SFDA excipient quality and supervision regulations, which it says are largely consistent with its own guidelines.
Chinese companies exporting drugs in bulk will come under the microscope next month when the Indian government sends a team of officials to inspect manufacturing plants.
Open source clinical trial software company OpenClinica has launched a marketing agreement with Athena Healthcare Consultancy to work within the Chinese market.
