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Manufacturing

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China Alarms Excipient Suppliers With Proposed Requirement To Share Proprietary Information

China’s Food and Drug Administration has proposed a regulation that would require excipient suppliers to disclose information that is above and beyond what is needed to demonstrate safety of pharmaceutical ingredients and that poses considerable IP risk to excipient suppliers, industry official says.

 

Manufacturing Quality China
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Performance-Based Conditions Could Ease Post-Approval Changes For Process Analytical Technologies, Experts Say

Pharmaceutical industry officials are promoting the idea of “marrying” the concepts of performance-based approaches and process analytical technology in the draft ICH Q12 guideline. Embedding this idea in ICH Q12 would give industry more flexibility in managing post-approval changes and aligns with the guideline’s concept of lifecycle improvement.

Manufacturing Quality United States

Latest From Manufacturing

EU Proposal To Restrict Microplastics In Pharmaceutical Ingredients Has US Excipient Industry On Edge

A proposal by the European Chemicals Agency that would restrict the use of microplastics in pharmaceuticals in the EU under its REACH regulation has come under attack by the US excipient industry. Officials argue that the proposal is misguided in that it considers all polymers to be microplastics and would unnecessarily restrict the availability of medicines that contain polymers in formulations.

Europe Manufacturing

US FDA's New Global Office Aims To Elevate and Enhance Agency’s Role On World Stage

There is growing recognition that the US FDA can use trade agreements to help confront the challenges of globalization and that these agreements can play an increasingly important role in fostering regulatory alignment and improving the quality of imports, agency official says.

Manufacturing Quality

US FDA ‘State Of Quality’ Report Targets Unreviewed, Uninspected Risks

The poorest-quality pharmaceuticals consumed in the US are the ones FDA has never reviewed, or are from sites the agency has never inspected, regardless of country of origin; the agency’s inaugural ‘State of Quality’ report contains some surprising findings.

 

Quality Manufacturing

Brexit Relief For Pharma As EMA Grants Most Batch Testing Exemptions

Of the 60 or so applications the European Medicine Agency has received from drug companies hoping for more time to move their batch testing sites from the UK to the EU, about 50 have been successful.

Brexit Manufacturing

South Korea Passes EU's GMP Equivalence Assessment For APIs

The European Commission took four years to evaluate South Korea's regulatory framework for active pharmaceutical ingredients and to conclude that it is in line with EU standards.
Europe South Korea

Major Upgrades In Store For The US FDA's Inactive Ingredients Database

A US FDA official has announced that major revisions are underway to address problems with the agency’s Inactive Ingredient Database. These include replacing potency limits with a maximum daily exposure limit and adopting standard terminology for routes of administration. In its current form, the IID has been a source of confusion for industry.

Manufacturing Quality
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