European Regulatory Roundup: EMA's New Phthalate Guideline (1 December 2014)

Regulatory NewsRegulatory News | 01 December 2014 |  By 

Welcome to our European Regulatory Roundup, a new weekly overview of the top EU regulatory news.

EMA Adopts Final Guidelines on Shared Facilities, Phthalate Excipients

The European Medicines Agency (EMA) has released its final guidance on the use of phthalates as excipients and the setting of exposure limits at facilities that manufacture multiple products. Both documents are set to come into force in June 2015, around 30 months after the initial drafts were agreed on by the safety working party.

EMA has made substantial changes to the shared facility exposure limit guidelines since releasing a draft almost two years ago. The final document has been restructured to separate advice on how to deal with certain types of materials — such as those that are genotoxic — from the general guidance on setting health-based exposure limits.

The regulator has also removed some text from the final draft. A line stating that dedicated facilities must be used when scientific data are unable to support threshold safety values or in situations where the risk cannot be controlled has been cut. EMA also removed a reference to the old approach of limiting the level of a contaminant to 1/1000th of the lowest clinical dose.

Many core elements of the text are unchanged, though. EMA has kept the permitted daily exposure formula it proposed in the draft and has carried over the bulk of the supporting text, too. Companies already manufacturing multiple human drugs at one facility have one year from publication of the text to comply. EMA has given manufacturers of animal drugs two years to adapt their practices.

The final guidelines on the use of phthalates as excipients have undergone fewer changes. The addition of a list of definitions is the most apparent difference between the final guidelines and the draft.

Shared Facility Guidelines I Draft I Phthalate Excipient Guidelines I Draft   

CHMP Recommends OTC Status for Emergency Contraceptive

The Committee for Medicinal Products for Human Use (CHMP) has recommended making the emergency contraceptive ellaOne available without a prescription. CHMP made the decision during a recent meeting, at which it also recommended approving 10 new drugs and discussed the safety of Amgen and Servier’s heart drug.

EMA approved ellaOne as a prescription drug in 2009, and CHMP has now revised its position in light of post-approval safety data. CHMP found the drug has a comparable safety profile to emergency contraceptives that are already available without a prescription — namely levonorgestrel-based products — and as such recommended changing its status. ellaOne is approved for use up to 120 hours after unprotected sex, compared to 72 hours for levonorgestrel-based products.

CHMP also issued opinions on 10 new drugs, all of which it recommended for approval. Drugs from AbbVie, Boehringer Ingelheim, Celgene, Merck, Novartis and Teva were among the batch of positive recommendations. CHMP reiterated the Pharmacovigilance Risk Assessment Committee’s (PRAC) recommendations on ivabradine — Amgen and Servier’s heart drug — too, and discussed a fatal case of progressive multifocal leukoencephalopathy in a patient taking Biogen Idec’s Tecfidera.

At a separate meeting, the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) found no consistent evidence of heart problems among men who take testosterone to treat hypogonadism. Recent studies have suggested a link between the treatment and increased risk of heart attacks, but PRAC — and subsequently CMDh — viewed the evidence as inconsistent. CMDh recommended a small change to the labeling of testosterone products, however.

ellaOne Recommendation I CHMP Meeting Notes I CMDh Report 

UK Information Chief Takes a Closer Look at Smart Medical Devices

The United Kingdom Information Commissioner’s Office (ICO) is trying to learn more about how the healthcare system is using and managing medical devices. ICO is particularly interested, it said, in the policies and processes covering Internet-enabled medical devices and health apps that gather patient data.

Inside Medical Devices reports ICO has published a short, anonymous online survey to collect details of how the healthcare system is managing the evolution of medical devices into Internet-enabled data-gathering tools. The survey probes whether organizations have policies to ensure the secure use of mobile devices or processes for decommissioning tools that may contain personal data.

Regulators and watchdogs on both sides of the Atlantic are taking an interest in how data collected by wearables and other devices are used and stored. ICO currently appears to be gathering information on the topic, but it can take action if necessary. Last month, ICO ordered a hospital to improve its data safeguards after patient records were left in a supermarket. ICO has previously warned Google, too. 

Inside Medical Devices I Survey

Other News:

MHRA has released a case study about the development of an AstraZeneca manufacturing plant. The document is intended to show how companies can work with the regulator to smooth the adoption of innovations. AstraZeneca praised MHRA for providing early feedback on the regulatory implications of a novel sterile manufacturing process. Press Release

European industry commissioner Elżbieta Bieńkowska has committed to supporting the rapid adoption of new medical device legislation. Bieńkowska was controversially given control of the medical device sector as part of a reshuffle in the European Commission. The health commissioner, Vytenis Andriukaitis, said little about pharmaceutical regulation at his hearing. Commissioner Commitments

MHRA has again warned of a potential breakdown in the safety alert process for medical devices. In October, MHRA reminded healthcare practitioners of the importance of responding to safety alerts about medical devices. Now, it has given an example of the problem. Smiths Medical issued a notice about its pumps but has received too few replies to know if people have acted on its advice. Alert

UK Life Sciences Minister George Freeman has explained why he is in a hurry to push through a review of how drugs are developed and approved. With an election scheduled for May 2015, Freeman’s long-term job prospects are uncertain. By starting the independent review — as well as assessments of MHRA and NICE — now, Freeman has set the agenda in motion. Financial Times

MHRA has issued an alert about Philips Healthcare’s Gel-E Donut and Squishon 2 neonatal and pediatric support products. Mold is growing in some of the devices. MHRA also posted a recall notice about three batches of mitoxantrone manufactured by Hospira. Stability studies of some products in the batches have found adverse impurity profiles and low potency. Device Alert I Drug Alert

EMA has released a guide to explain how to request access to unpublished documents it possesses. The regulator adopted an access-to-documents policy in 2010 and reviewed its approach last year. The review led to the publication of the guide, which answers 12 questions people may have about the process. Statement I EMA Guide

The French government has negotiated a 27% discount on the sticker price of Gilead Science’s hepatitis C blockbuster, Sovaldi. Gilead is charging France $51,400 for a full course of the treatment, significantly less than it costs in the US and reportedly the lowest price in Europe. Pharmalot

EMA has adopted a new policy for handling conflicts of interest among members of its scientific committees. The regulator has contended with high-profile cases of potential conflicts in recent years, notably when Thomas Lönngren stepped down as executive director in 2010. Regulatory Focus I EMA Statement

European authorities have awarded a CE Mark to Covidien for its Nellcor oxygen monitor. The device monitors a patient’s pulse and oxygen levels at home. Caregivers are alerted if oxygen levels fall below a certain level. Mass Device


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