In this week’s news, China passes revamped drug production and importation laws with implications for CDMOs, US FDA inspections down, enforcement actions up and more…
New Chinese laws, an opportunity for CDMOs
China has passed its “Drug Administration Law,” a wide-ranging body of legislation that will impact many areas of pharmaceutical production in the country, including CDMOs.
The law – which was formally adopted on August 26 – will go into effect on December 1 according to Chinese Government newswire Xinhua.
The Government said the law is “aimed at addressing prominent problems of the pharmaceutical industry, such as counterfeit and substandard drugs and high drug prices.”
The DAL outlines several measures related to drug and API importation, which could impact how pharmaceutical companies work with contractors according to analysis by Ropes & Gray.
Under current regulations, approvals for imported drugs are issued to foreign marketing authorisation holders while, in contrast, approvals for China-made drugs are issued to firms that actually produce them.
However, the new laws allow for marketing authorisations to be transferred from one company to another without changing contract manufacturers.
According to Ropes & Gray, “These changes could potentially result in a convergence of the bifurcated pathways and enable Chinese MAHs to work with overseas CMOs.
“Likewise, foreign MAHs may also choose to work with CMOs in China and restructure their supply chains. If such theses become true, foreign companies will more likely transact with Chinese companies to divest their product portfolios or localize the production of their assets in China.”
Read the full analysis here.
US FDA ups foreign enforcement actions
The number of US FDA inspections fell in 2019 as a result of the Government shutdown and the agency’s pact with the EMA.
According to an FDAlaw blog post, agency inspectors have visited fewer drug manufacturing plants, both foreign and domestic, so far in 2019 than in previous year.
However, the authors point out the number of enforcement actions – warning letters etc. – has increased, with companies in China and India seeing much of the increase.
“We have noticed that a lot of the GMP Warning Letters from CDER emanate from inspections FDA conducted in China and India.”
The increase is part of a decade long pattern according to the authors.
“Over the last nine years, selected types of drug inspections in India and China showed a higher rate of classifications of Official Action Indicated and Voluntary Action Indicated – meaning that there are significant corrections that inspected facilities are required to perform- than do FDA inspections of facilities in the United States.”
Read the full blog post here.
Pharmas should look at high maintenance CDMOs, says expert
Drug companies should check how often potential contractors update and repair their manufacturing plants before hiring them says an expert.
The advice was presented in a Bioprocess Insider article last week.
John Godshalk, a senior consultant at Biologics Consulting, told the publication “Maintenance is an important regulatory concern and some CMOs do better at it than others.
“From a cost perspective, it is tempting to do deferred maintenance and save some moment but at some point it will catch up on you.”
Read the full article here.
Also in the news
The Pink Sheet reported that the US FDA is being urged to reconsider the level of metal contaminant information it requires from drug manufacturers.
The US FDA wrote about ongoing efforts to police the quality of Angiotensin II Receptor Blockers.
Several babies in Spain have developed “werewolf syndrome” as a result of being given incorrect medicines. Read the full Guardian report here.
The Dutch Government is considering naming and shaming drug makers that fail to justify the price of their products. See Stat’s coverage here.
RAPS reported changes the EMA has suggested the US FDA makes to its draft guidelines on biosimilars.
Ajinomoto Bio-Pharma Services will buy the remaining 50 interest in Granules OmniChem Private Limited (GOC), its joint-venture with Granules India. The JV was formed in 2011 to produce APIs for the drug industry. See press release.
Private equity firms Water Street Healthcare Partners and JLL Partners have bought Thread, a provider of tech that supports the modernization of clinical studies. See press release.