Sector News

EMA, FDA form transatlantic pact on site inspections

March 6, 2017
Life sciences

Regulators in the EU and the US have signed a transatlantic agreement to recognise inspections of manufacturing sites for human medicines carried out in their respective countries.

Under the new deal, regulators on both sides of the Atlantic will now rely on each other’s inspections in their own territories to ensure that sites operate in compliance with Good Manufacturing Practice (GMP), to optimise use of capacity and reduce duplication.

The agreement follows robust evidence that EU and US systems have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines.

The move will enable both EU authorities and the US Food and Drug Administration to hone their focus on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured, to ensure their quality, safety and efficacy.

Around forty percent of finished medicines marketed in the EU come from overseas and 80 percent of the manufacturers of APIs for medicines available in the EU are located outside the Union.

According to the European Commission: “The enhanced cooperation with US regulatory authorities will improve the EU’s ability to identify and address problems at factories before they become a public health risk. It will also reduce the administrative burdens and costs facing pharmaceutical manufacturers, including smaller producers”.

By Selina McKee

Source: Pharma Times

comments closed

Related News

January 22, 2023

Sun Pharma to buy Concert Pharmaceuticals for $576m

Life sciences

Sun Pharmaceutical Industries has signed a definitive agreement to buy all outstanding shares of Concert Pharmaceuticals in a deal valued at $576m. Under the deal, the company will buy all shares of Concert common stock through a tender offer for $8.00 per share in cash upfront payment.

January 22, 2023

Novo Nordisk diabetes pill wins FDA approval for first-line use

Life sciences

The Food and Drug Administration on Thursday approved Novo Nordisk’s diabetes pill Rybelsus as an initial treatment to lower blood sugar levels, a label expansion that will allow it to compete more directly with other oral drugs from Merck & Co. and Eli Lilly.

January 22, 2023

Bayer feeling more heat from activist investors, this time from Bluebell

Life sciences

Since making an ill-advised $63 billion buy of Monsanto in 2018, Bayer has faced heaps of pressure from investors that have called for the company to oust its leadership and to restructure. Now comes new pressure from a familiar source. Bluebell Capital Partners has bought an undisclosed stake in the company and is agitating for a breakup, sources told Reuters.

How can we help you?

We're easy to reach