Astellas’ drug fezolinetant (Veoza) has been approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the prevention of hot flashes during the menopause.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for Pombliti + Opfolda, a two-component therapy to treat Pompe disease.
The Medicines and Healthcare Products Regulatory Agency has released proposals to bolster trials legislation, asking citizens for input on the suggestions.
Organizations or individuals desiring change is often the reason for retirements, but the timing is often crucial and so it proved for two major institutions in the UK.
Pharma and regulators are using machine learning to accelerate various pharmacovigilance activities – as the number of adverse event reports increases 10-12% each year, says Eli Lilly advisor.
Sharp’s clinical services center is approved by the MHRA and now ready to offer services for serialization and trial management while reducing carbon footprint with the addition of solar panel systems.
Upperton Pharma’s new and expanded facilities received a positive inspection from MHRA, enabling both research and development and clinical manufacturing at the site.
The UK Government last week provided an update on the regulation of clinical trials in the event of a “no deal” Brexit, with a commitment to ensure any new requirements are not “unduly burdensome.”
Three family members charged with producing and supplying unlicensed medicines in the UK used pressing equipment and dyes imported from China, says MHRA.
It has been revealed that the EMA is awarding significantly fewer contracts to evaluate the application of new drugs to the MHRA, as the Brexit deadline nears.
In an update on the implementation of the new Clinical Trials Regulation, the MHRA expresses increased confidence that the UK will exit the EU with a deal – and reaffirms its commitment to align with parts of the legislation “within the UK’s control.”
Apotex had seemed to be having a good week after it received US FDA approval for its generic product, only for it to then be on the receiving end of a warning letter the following day.
Evertogen Life Sciences Limited should recall drugs made at its facility in Mahabubnagar, India according to the MHRA, which identified critical quality and data integrity problems during an audit in August.
The UK MHRA saw an increase in sterility issues at drug plants in 2016 although quality system problems remained the most common deficiency seen during inspections.
The UK regulatory agency is recruiting for medical assessors, but with drug-device combinations, biologics and personalised medicines making the job more complex, do you have what it takes?
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is working on a pilot project investigating the feasibility of inspecting pharmacovigilance contract service providers as it’s becoming increasingly common for a MAH (marketing authorisation...
Following Wockhardt’s decision to cease supplying APIs to the EU market, the UK drug regulator MHRA (Medicines and Healthcare Products Regulatory Agency) has updated its statement of noncompliance to include all APIs made from the India-based manufacturer.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) will launch a scheme next month to allow doctors to prescribe medicines without a marketing authorisation to patients with life-threatening conditions.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has withdrawn its good manufacturing practice certificate for Wockhardt’s Chikalthana, India-based plant due to cGMP violations.
The MHRA says it will assess the quality of active pharmaceutical ingredients (APIs) imported from outside the EU at manufacturers’ facilities rather than at UK borders.
Wockhardt remains confident its troubled manufacturing facility in India will be back up and running in three months after receiving a certificate of non-compliance from the MHRA.
Fraudulent manipulation of preclinical trial data is rare and the regulations that cover this type of research do not need to be revised according to the UK MHRA.
Serious consideration was given to transferring MHRA clinical trial functions to the HRA after it faced criticism including reports of unprofessional and intimidating GCP inspections.
The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has ordered the recall of 100 batches of drugs sold by generics firm Karib Kem Pharm.
Increasing bureaucracy in clinical research in the UK is posing a threat to the industry, according to a report published in the British Medical Journal.
in-PharmaTechnologist.com's periodic round-up of developments in
the field of pharmaceutical facilities includes news of two
environmental fines, MHRA plant approval and a strike at Teva.
The pharmaceutical industry in the UK faces tougher legislation on
the disclosure of adverse events in clinical trials following the
MHRA's thwarted attempt to prosecute GlaxoSmithKline for allegedly
withholding information about...
UK-based William Ransom & Son has been advised to voluntarily
recall certain products following a false contamination scare at
its Witham, Essex, facility.
The UK has become an unlikely hub for drug counterfeiters, with the
UK Medicines and Healthcare products Regulatory Agency (MHRA) last
week launching its new three-year action plan to tackle the recent
surge in drug fakes head on.
In the latest episode of illegal drug trading, a hoard of
unlicensed medicines was seized by the UK Medicines and Healthcare
products Regulatory Agency (MHRA) last week, taken from a London
lock-up containing a stash of various male...
Although clearing Parexel from contributing to the recent drug
trial disaster, a final UK Medicines and Healthcare products
Regulatory Agency (MHRA) report slammed the US firm for making a
number of basic errors during the trial process.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA)
has said it has so far found no evidence of wrongdoing in the human
trials of the monoclonal antibody TGN1412, which US contract
research firm Parexel carried...
The UK MHRA will allow salt and ester variants of active drugs to
be submitted for approval as generics using abridged applications,
following the EU's lead.
