In this week’s news, EMA address bias concerns, China sets up regulatory CoE, and more…

EMA moves to address perception of bias in drug approval processes

The European Medicines Agency (EMA) will adopt recommendations made by the EU ombudsman to avoid the perception of bias in it drug approval reviews.

The European regulator made the announcement last week, explaining it has decided to implement suggestions made by Emily O’Riley following a 2017 review of its approval practices.

It wrote, “Your recommendations will significantly help in striking even further a good balance between providing the best possible scientific advice and guaranteeing the independence of the medicine assessment which takes place at a later stage, taking due consideration of expertise needs and while, most importantly, ensuring that procedures are correctly understood and perceived by the general public.”

Initially, the EMA was less than enthusiastic about the review. In 2017 Guido Rasi said “no single person has the final say on a medicine’s approval,” arguing that the agency already had measures in place to prevent conflicts of interest.

China sets up drug and food regulatory centre of excellence

China has set up a regulatory centre of excellence for drugs and food in Beijing in collaboration with the United Nations.

The centre of excellence – which will have an initial budget of $500,000 – will focus on the creation of a food and drug safety training system.

According the United Nations’ industrial development organisation (UNIDO) will provide capacity support for food applications with the China Food and Drug Administration’s Institute of Executive Development (CFDAIED) focusing on the drug sector.

See announcement here (Mandarin).

Also in the news

Bioprocess Insider looked at Novartis’ plan to acquire the Medicines Company and its cholesterol-busting RNA interference drug.

RAPS covered analysis of US efforts to address high drug prices. The analysis suggests the Trump administration’s proposal to align US drug prices with international prices would “pale in comparison to the major impact House Speaker Nancy Pelosi’s (D-CA) drug pricing bill would have.”

Zolgensma is set to be used in Europe according to a report by Politico. How the world’s most expensive drug will be paid for is a point of debate.

The lack of people with cell and gene therapy manufacturing skills in the UK is a concern according to analysis by the Cell and gene therapy catapult. See the full story at Bioprocess Insider.

CDMO trends

Some developments of note in the contract manufacturing and services space.

RedHill Biopharma has contracted Recipharm to make commercial supplies of the Helicobacter pylori infection treatment Talicia. The drug is due to be launched next year.

Prestige Biologic has hired Dongkook Pharmaceutical to make an unnamed biosimilar product for the Korean market. Under the deal, Prestige will supply Dongkook with API which will make the finished product at its plant in Jincheon, Chungbuk.

Sanofi has contracted May & Baker Nigeria to make medicines for the local market.