European Regulatory Roundup: Swissmedic Clarifies Stance on EC Certificates for Devices (5 January 2016)

Posted 05 January 2017 By Nick Paul Taylor

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

Swissmedic Clarifies Stance on EC Certificates for Devices

The Swiss Agency for Therapeutic Products (Swissmedic) has given medical device manufacturers affected by the fall in the number of notified bodies one year to restore the legal conformity of their products. Swissmedic’s approach to the situation follows the harmonized procedure adopted by the European Union.

Notified bodies are organizations that verify the conformity of medical devices to legislative requirements. Some medical device manufacturers were left without notified bodies after the EU strengthened its market surveillance activities in response to the defective breast implant scandal. The EU backed up the move to a more specific and stringent approach by running 55 international assessments of notified bodies organizations. This cut the number of notified bodies from 80 to fewer than 60.

One consequence of the fall in the number of notified bodies is approximately 3,000 EC certificates are no longer monitored by a notified body. This has raised doubts about the regulatory status of medical devices covered by such unmonitored certificates. Specifically, the situation has created uncertainty about the legality of placing a medical device on the market for the first time when it has an affected certificate. The EU decided to grant manufacturers with affected certificates a “period of grace” in October, and Swissmedic has now followed suit.

The upshot is companies whose notified bodies were partially or wholly de-designated have up to one year to restore the legal conformity of their products. Swissmedic will refrain from taking action against companies that put products on the market using the identification number of their de-designated notified body during this period of grace, provided they meet certain conditions. To benefit from the transition period, manufacturers must ensure the safety of their device, meet the essential requirements and show they have started the process of renewing their EC certificates.

Manufacturers must send Swissmedic written confirmation they meet the conditions within 30 days of their notified body being de-designated. Swissmedic also expects manufacturers to include a copy of the EC certificate, declaration of conformity, written confirmation from the new notified body that the renewal process has begun and a timeline for remedying the situation. Swissmedic acknowledges the move to a new notified body is not an easy process, and as such has given manufacturers 12 months to complete the transition.

The agency will continue to issue export certificates for affected EC certificates during the one-year transition period.

Swissmedic Notice

CHMP Closes out 2016 by Finalizing a Clutch of Guidelines

The Committee for Medicinal Products for Human Use (CHMP) closed out 2016 by finalizing six guidelines, the most notable of which is a long-gestating document on the clinical development of treatments for pain.

Members of the Biostatistics Working Party agreed on the original draft of the guideline in 2012. Since then, the text has been through two public consultations and been reviewed by the Central Nervous System Working Party and other groups within the European Medicines Agency (EMA). Late last year, the process culminated in CHMP adopting a final version of the guideline that will come into force on 1 July.

The final text has remained true to the overarching goal of the 2011 concept paper that started the process of creating the guideline. Publication of the concept paper was prompted by a belief the current practice of maintaining separate guidelines for nociceptive and neuropathic pain was outdated. The mechanistic distinction between the two types of pain is still valid for some forms of the condition, but the dividing line is vague in chronic pain. As such, CHMP saw, and still sees, value in merging the two documents.

In its final form, the guideline discusses general considerations for clinical development, such as pharmacokinetics and clinical efficacy, before assessing specific considerations for testing drugs against different types of pain. This marks a shift from the first draft of the guideline, which focused more on nociceptive and neuropathic pain than cancer pain, chronic pain and other specific conditions. The shift in focus has allowed CHMP to provide details on how sponsors can design trials that avoid the high dropout and placebo response rates that blight some pain studies.

CHMP finalized the text on the same day it adopted guidelines on demonstrating bioequivalence to five products, namely tablets or capsules containing everolimus, fingolimod, paliperidone, pazopanib and a combination of levodopa, carbidopa and entacapone. The guidelines detail the study designs sponsors should use when trying to demonstrate the bioequivalence of their candidate to the reference product. Each of the guidance documents will come into force on 1 July. 

Pain Products, Everolimus, Fingolimod, Paliperidone, Pazopanib, Levodopa

CVMP Adopts Three Guidelines on Minor use, Minor Species Products

The Committee for Medicinal Products for Veterinary Use (CVMP) has adopted three guidelines on the requirements for minor use, minor species (MUMS) products. The guidelines cover efficacy, quality and safety requirements for the subset of veterinary medicines.

MUMS designation serves a similar purpose in animal medicine as orphan drug status does in human therapeutics. As such, the three guidelines try to reduce the data requirements placed on developers of MUMS products and, in doing so, stimulate the advance of drugs that tackle unmet needs in animal health.

CVMP is most open to lowering the data requirements of products that are already established as treatments for major species or feature active ingredients from well-known classes of substances. Officials will decide the extent to which data requirements can be lowered for products based on novel active pharmaceutical ingredients on a case-by-case basis.

“For novel active substances, and for those where limited information is available relating to their use in any animal species, comprehensive information relating to use in the target species will be required,” CVMP wrote in the guideline on efficacy data requirements. The quality and safety texts take a similar approach to when it is feasible to accept a reduced data package.

The guidelines will come into effect on 1 July.

Efficacy, Quality, Safety

Sanofi, MHRA Warn of Braille Error on Drug Packaging

Sanofi has warned of an error in the Braille on the packaging of some packs of its rheumatoid arthritis drug Arava. The French pharmaceutical company alerted regulators in the United Kingdom to certain batches after discovering the Braille on some packs said 20mg rather than 10mg.

That prompted the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to issue a Class 4 caution. The caution alerts healthcare professionals to four batches of Arava. Sanofi thinks one in five cartons in the batches are affected by the Braille error. MHRA views this as a risk to patients who rely on Braille to determine the strength of their tablets, but the products will stay on the market.

Rather than recall the batches, Sanofi and MHRA are advising people in charge of dispensing the drug not to give potentially affected packs to patients who rely solely on Braille to read the product information. Instead, healthcare professionals should give patients a pack from the one unaffected batch that is available. If a wholesaler lacks packs from the unaffected batch, MHRA is advising people to contact Sanofi. 

MHRA Notice

Other News:

Authorities in Greece raided the offices of Novartis as part of a bribery probe. Reuters

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, EC, MHRA

Tags: Swissmedic, European Regulatory Roundup, notified bodies, Braille

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