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Manufacturing

Set Alert for Manufacturing

Random Checks Now Routine: China To Inspect Your Factories Near And Far

An officially released new regulation in China legalizes overseas inspections of drug and device makers, making the risk-based inspections routine tasks that could also expand to manufacturers' R&D partners and third-party suppliers of ingredients, excipients or packaging materials.

China Manufacturing Regulation
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Latest From Manufacturing

Pharmaceutical Groups Urge FDA To Upgrade From NDC To GTIN To Avoid Conflicts With DSCSA

Pharmaceutical manufacturers and distributors complain that FDA’s plan to add digits to the NDC would be a mistake and could potentially conflict with global standards as well as the bar code technology systems put into place under the Drug Supply Chain Security Act. They suggest embedding the NDC into the GS1 Global Trade Identification number (GTIN) to avoid these conflicts.
Manufacturing Distribution

European Council Move Brings SPC Manufacturing Waiver A Step Closer

A proposed SPC manufacturing waiver – which would allow generic and biosimilar manufacturing within Europe during the SPC period – has taken a step closer to being realized after the European Council approved a mandate for negotiations with the European Parliament. However, it remains uncertain whether key elements desired by the off-patent industry will fall into place.

Europe Manufacturing

US FDA Brings Back Furloughed Workers To Inspect High-Risk Facilities

Though they remain unpaid, hundreds of furloughed FDA employees will return to duty to conduct routine surveillance inspections of high-risk manufacturing facilities.

Manufacturing Quality

Public/Private Cooperation, Tailored Assistance Deemed Key To Enhancing Quality Of US Drug Imports

Public health experts tell committee that much work lies ahead in strengthening the regulatory systems of low-and middle-income countries, and recommend ways to bolster these systems and improve the quality of imports.
Quality Manufacturing

PIC/S Considers New System For Monitoring Compliance By Members

As more and more regulatory authorities line up to join the informal co-operative scheme for pharmaceutical inspectorates, PIC/S, there are plans to discuss the possible introduction of an annual reporting scheme to check ongoing compliance by existing members.
International Manufacturing

EU Pharma Slams ICH Proposal For Selective Adoption Of Quality Guideline

An unprecedented proposal by the International Council for Harmonisation that would let member states selectively adopt certain parts of one of its quality guidelines has drawn criticism from EU pharmaceutical industry associations.
Europe International
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