In this week’s news, MHRA loses EMA review role early, China’s pharma market evolving, generic sector worried about US-Mexico trade plan and more…
MHRA to lose role in EMA drug reviews ahead of Brexit
The MHRA will no longer evaluate the safety of drugs on behalf of the EU after the EMA ended its involvement in preparation for Brexit.
According to a report in the Guardian, the MHRA will not be allocated new review work by the EMA because such assessments are not likely to be completed before the Government pulls the UK out of the EU next March.
Previously the UK regulator has played a major role in assessing the safety and efficacy of medicines sold in the EU. Some reports suggested the agency conducted as many as 30% of all reviews under the EMA’s prevue.
The EMA has also begun reallocating existing MHRA review contracts to regulatory agencies in EU member states.
The end of MHRA involvement in EU drug reviews is a major blow for UK Government efforts to try and maintain the agency’s links with the EMA.
China focuses on pharma industry
Regulatory measures introduced by the Chinese Government indicate the country is serious about improving its pharmaceutical industry according to an Economist report.
China has introduced a number of changes to how it assesses medicines in recent years. The main aim has been to accelerate review times to bring them in line with those in other major markets.
Much of the focus has been on overhauling the country’s regulatory agency – now called the China Drug Administration – according to the Economist article, which suggests that increased staffing levels and the relaxation of rules on clinical trials are reshaping the market.
The authors also suggest that the overhaul of the Chinese market is likely to be of benefit to international pharmaceutical firms. They suggest that larger companies are adapting to the changes more successfully than local manufacturers.
Read the full article here.
Generics firms call for rejection of US – Mexico biologics exclusivity deal
US, Canadian and Mexican generic drug groups want the US Government to rethink its new trade agreement with Mexico.
The US and Mexico announced their preliminary trade agreement last week, explaining that both parties had agreed to extend the exclusivity period for biologic drugs to 10-years.
At present, Mexico currently enjoys a period of five years of data exclusivity for biologics while Canada uses 10 years.
The Association for Accessible Medicines, Canadian Generic Pharmaceutical Association, and Mexican Association of Generic Medicines made their views on the exclusivity extension clear in a statement on Thursday.
They wrote “This provision would harm the growing biosimilar industry, which aims to provide price competition to some of the most expensive prescription drugs and allow patients to benefit from affordable medicines.
“The U.S., Mexico and Canada should reject these provisions, which would benefit brand name drug companies to the detriment of public health and the affordability of medical care.”
Also in the news
Pharmaintelligence has put together an infographic of the biggest players in the drug industry that covers how they have performed in 2018.