23-05-2019

PIC/S: TGA and Health Canada share experiences with mutually relying on other inspectors’ findingsn

(Source: RAPS 2019-05-24)

Almost a year after the Pharmaceutical Inspection Co-operation Scheme (PIC/S) adopted a new guideline allowing regulators to rely on their peers’ good manufacturing practice (GMP) inspections, Health Canada and Australia’s Therapeutic Goods Administration (TGA) shared some early results.

22-05-2019

R&D: Drug regulators look to harmonize how they tackle innovation

(Source: RAPS 2019-05-23)

The International Coalition of Medicines Regulatory Authorities (ICMRA) recently released a report on how various regulators worldwide are working together to better identify and address future regulatory challenges posed by new categories of therapeutics, like cell and gene therapies, and new tools for drug development, such as artificial intelligence (AI).

21-05-2019

EU: Update of EU recommendations for 2019–2020 seasonal flu vaccine composition

(Source: EMA 2019-05-22)

EMA has issued an update of the EU recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2019.

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