Regulatory in brief | paracetamol, ranitidine, GSK

Regulatory in brief | paracetamol, ranitidine, GSK

26 June 2020 - Deborah Wilkes

France is establishing national production of paracetamol, the European Medicines Agency (EMA) is set to take another look at ranitidine, and GlaxoSmithKline (GSK) Consumer Healthcare has recalled some children’s medicines.

France in paracetamol move

France is taking steps to ensure more medicines, starting with paracetamol, can be manufactured domestically.

The French government said the COVID-19 pandemic had highlighted the need to have an independent supply of medicines and medical devices.

Within three years, the government wants France to be capable of manufacturing, packaging and distributing paracetamol. It is working with Sanofi, Seqens and Taisho's UPSA.

Sanofi announced in March 2020 that it planned to create a European active pharmaceutical ingredient (API) supplier to “balance the industry’s reliance on API sourced from the Asian region” (click here to read the News story).

Europe to re-examine suspension of ranitidine

The European Medicines Agency (EMA) is starting a re-examination of the Committee for Medicinal Products for Human Use’s (CHMP’s) recommendation that all medicines containing ranitidine should be suspended in the European Union.

One of the marketing authorisation holders had requested a re-examination, said the EMA, adding that upon receipt of the grounds for the request, the CHMP would start a re-examination and issue its final recommendation.

The CHMP’s recommendation was announced in April 2020 (click here to read the News story).

GSK recalls some children’s medicines

GSK Consumer Healthcare has voluntarily recalled some children’s cough medicines in the US due to “incorrect dosing cups”.

The company said the dosing cups were missing some graduation markings.

The recall applies to two lots of Children’s Robitussin Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp Cold and Cough.

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EMA COVID-19 Sanofi Consumer Healthcare Taisho

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