In this week’s news, EMA says CDMOs can help stop shortages, EMA rejigs rules for baby studies, MHRA advices firms shipping to Italy and more…
CDMOs can help pharma spot potential drug shortages
The EMA says contractors can help pharmaceutical firms detect potential drug shortages.
The Amsterdam-based regulator made the comments in two guidance documents last week. The first document covers reporting obligations and makes clear what issues – interruptions, discontinuations etc – need to be logged.
Contract manufacturers have a role to play according to the agency.
It wrote, “An example of this is where a single manufacturer is contracted to produce medicinal products or active substances for a number of MAHs. The impact of a manufacturing issue in this case could extend beyond one specific product and it is important to monitor these signals. All operators are expected to monitor for signals.”
The second guidance document is focused on public communication. The EMA said, “Medicine shortages or problems relating to the availability of medicines are a multifactorial problem involving a wide range of stakeholders.”
“Processes for communication to the public are already in place at EU and national level, however communication practices vary amongst member states and there is a need to review and consolidate existing practices into a single document providing clear and harmonised guidance.”
EMA rejigs guidelines for preterm studies
In other news, the EMA has revised its guidelines for clinical studies involving premature babies after feedback from the drug industry.
The agency put forwards its ideas in a concept paper last year. Most of the feedback was positive. However, some respondents raised concerns about how a “preterm neonate” is defined, prompting an agency rethink.
See the full feedback document here.
UK issues guidance on EU packaging safety features to use in Italy
The UK MHRA has moved to help firms supplying Italy to comply with the country’s labelling laws.
The UK regulator published a “how to” guide last week, explaining that it is designed to help firms adhere to rules stipulated by the EU Falsified Medicines Directive.
The specific focus is on how manufacturers making drugs for the Italian market should implement the requirements for packaging safety features, which came into effect in February.
Under the directive, drug packs should have a unique identifier and tamper evident features. However, as the MHRA points out, the directive does not specify the type of safety features. Instead, individual states set their own guidelines.
The MHRA wrote, “The Italian Medicines Agency (AIFA) have issued guidance on the security label used by Italy; the ‘Bollino’. This system uses a serial number on a 2-layered adhesive sticker / label which can be tracked via a central database must be applied to each pack.
“The upper label is removed upon dispensing in Italy leaving a voided area and strip containing the repeated serial number. AIFA state that either a missing ‘bollino’ or bearing a falsified ‘bollino’ should be considered as a falsified medicine and reported via the required channels.”
Also in the news
US President Donald Trump has a plan that would allow the US to buy medicines based on prices paid by other countries. See the full Bloomberg report here.
UK advertising regulators have criticised Sanofi for paying an Instagram user to promote its pharmacy-only Phenergan Night Time (promethazine hydrochloride) tablets on a parenting blog. See RAPS’ take here.
The EMA and the European Commission have urged pharmaceutical companies to make greater efforts to publish clinical trial results.
Some noteworthy developments in the CDMO space this week:
Brammer Bio, Thermo Fisher Scientific’s gene therapy production unit, has been contracted to help Amicus Therapeutics’ develop products for the treatment of Batten’s disease and various other conditions.
In related news, Amicus has hired Paragon Gene Therapy, part of Catalent, to help it manufacture product for clinical trials.
Lonza has bought a sterile fill finish facility from Novartis.