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