EU Regulatory Roundup: Noncompliance actions against Indian drugmakers drop to new low

RoundupsRoundups | 18 June 2020 |  By 

The number of European manufacturing noncompliance notices sent to Indian drugmakers fell to a new low last year, with just one good manufacturing practice (GMP) notice issued to an Indian company in 2019 compared to at least five annually over the previous four years, the European Medicines Agency (EMA) reported.
Indian drugmakers received a significant minority of all the GMP noncompliance notices issued by regulators in the European Economic Area (EEA) from 2015 to 2018. In 2016, half of the 24 notices issued globally by EEA agencies went to Indian companies. EEA agencies issued as many or more noncompliance notices to firms in India than to firms any other region in 2015, 2016 and 2017, and sent just one less to the country than they posted across all of their home region in 2018.
Last year was different with just one GMP noncompliance notice issued to an Indian company. The drop occurred despite EEA agencies issuing a similar number of GMP certificates to Indian companies as they had in previous years.
The overall number of notices about GMP failings was in line with previous years. Chinese companies received four notices, in keeping with the average across recent years, and companies in the EEA received 11 statements. Across the previous four years, EEA-based manufacturers received around six noncompliance notices a year, on average.
It is unclear whether the low level of compliance failings in India is an anomaly or a sign that quality practices in the country are improving. An annual report published by the US Food and Drug Administration (FDA) earlier this month indicates that the EEA data might be an anomaly. Last year, FDA gave Indian manufacturers an average quality score of 6.8, down from 7.0 in 2018. If quality practices have improved in India, the change is yet to show up in FDA’s GMP inspection scores.
EMA Report
Dutch agencies execute authorization, reimbursement in parallel
Authorities in the Netherlands worked in parallel for the first time to complete the authorization and reimbursement assessments in the new drug approval process for Novo Nordisk’s diabetes drug Rybelsus.
Typically, the Dutch National Health Care Institute (ZIN) only starts assessing whether to reimburse a product after the Dutch Medicines Evaluation Board (MEB) has authorized it for use. That process, versions of which are in place across Europe, causes a delay in access to medicine for patients and a delay in commercial sales for the manufacturer.
MEB and ZIN set up a parallel procedure pilot to eliminate the wait. In the pilot, ZIN starts its reimbursement assessment while MEB is deciding whether to authorize a medicine.
Last week, Novo Nordisk’s oral GLP-1 receptor agonist Rybelsus became the first product to complete a parallel assessment. EMA published the European public assessment report (EPAR) for Rybelsus on 27 May. ZIN was able to start its work prior to completion of the EPAR and file its recommendation on 4 June.
MEB thinks shortening the lag between EPAR publication and submission of reimbursement advice to around one week will result in patients in the Netherlands being among the first in the European Union to access Rybelsus. EMA now offers parallel consultations with the European Network for Health Technology Assessment, but the actual authorization and reimbursement processes generally still happen in sequence.
MEB and ZIN are now preparing to assess a second product through the pilot project.
MEB Notice (Dutch)
MHRA, too, quashes HCQ trials
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has stopped enrollment in clinical trials of hydroxychloroquine (HCQ) in COVID-19 patients.
Organizations including the World Health Organization and the French National Agency for Medicines and Health Products Safety stopped enrollment in HCQ trials in May in the wake of a now-retracted publication in The Lancet. MHRA, however, held off on taking immediate action in favor of waiting for advice from the Commission on Human Medicines.
The Commission reviewed data from HCQ clinical trials, including from the UK’s RECOVERY trial, which failed to find strong evidence that the drug improves survival in COVID-19 patients.
Based on the review, MHRA has asked the sponsors of COVID-19 trials of HCQ to stop enrollment. The enrollment ban will remain in place until new data supporting the use of the medication is available and additional safety measures have been put in place.
MHRA Notice
Denmark lifts paracetamol restrictions as COVID-19 concerns recede
The Danish Medicines Agency (DKMA) has lifted restrictions it placed on the sale of paracetamol at the start of the COVID-19 crisis.
As COVID-19 swept across Europe in March, DKMA began requiring people to have a prescription to buy paracetamol in a suspension dosage form for use in children. DKMA took the action to ensure a formulation needed by very young children remained available amid rising demand for paracetamol and concerns about the ability of medical supply chains to cope with COVID-19.
This week, DKMA lifted the restrictions, freeing people to buy paracetamol suspensions over the counter (OTC) for the first time since March. The action comes weeks after DKMA began allowing consumers to buy more than one pack of OTC medicines at a time.
DKMA’s back-to-back actions add to evidence that concerns are receding regarding the impact of COVID-19 on certain supply chains. Earlier this week, Fimea said the availability of medicines in Finland has held up during the pandemic.
DKMA Notice, Fimea Notice (Finnish)
Fimea seeks feedback on revised pharmacovigilance guide
The Finnish Medicines Agency (Fimea) has shared draft pharmacovigilance guidance for consultation. Fimea has created a template for pharmacovigilance plans in conjunction with the guidance update.
In the template, Fimea addresses topics including the identification of risks associated with a drug, monitoring the effects of medicines and the reporting of adverse events. The current version of the template and associated guidance grew out of consultations, including a workshop, dating back to last year.
Select organizations are now assessing how the template works in practice in a pilot project. Fimea will use the pilot project to inform the evolution of the template, but also wants feedback on the document and associated guidance from organizations not involved in the evaluation process.
Fimea is accepting feedback on the draft until 19 August.
Fimea Notice (Finnish)
Other News:
EMA has renewed its confidentiality agreement with Health Canada. In renewing the agreement, which first came into force in 2007, EMA and Health Canada have added references to personal data, which is not meant to be exchanged between the organizations under the terms of the arrangement. The agreement is permanent, unlike its predecessors that expired after five years. EMA Agreement


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