No Shocks Expected In EU Quality Guidance For Drug-Device Combinations
Executive Summary
Long-awaited draft EU guidance on the quality requirements for integral and non-integral drug-device combination products will be published very soon.
Much-awaited draft guidance on quality expectations for EU marketing authorization applications for integral and other types of drug-device combination products is due to be published for public consultation shortly.
The draft document is particularly pressing for companies making drugs with integral devices in view of a new requirement that Europe’s Medical Device Regulation (MDR) is introducing for them. It is on track for release in the first few days of June.
The draft is unlikely to contain any bombshells for companies, according to the European Medicines Agency’s Armin Ritzhaupt, who was speaking at a session on the new requirement at last week’s Regulatory Affairs Professionals Society (RAPS) 2019 Europe conference in Brussels, Belgium.
“I know that everyone is waiting” for the draft document and would have liked it to have been published before now, observed Ritzhaupt, who works at the EMA's Regulatory Affairs Office.
“But rest assured, when the guidance comes you’re not going to find a huge surprise. Many of you will have dealt with these types of products in the past and you will recognize elements in the guidance.”
The new draft guidance will contain “clear instructions” on what to submit in a dossier – Armin Ritzhaupt, EMA
The draft guidance follows on from a concept paper the EMA released in November 2016 on the quality requirements for medicines that contain a device component for their delivery or use. It will cover integral products such as pre-filled syringes and auto-injector as well as non-integral products, for example where the device is co-packaged with the drug or where the drug and device are supplied separately.
As was noted in the concept paper, guidance is needed on the quality aspects of the dossier requirements for drug-device combination (DDC) products for marketing authorization applications, line extension applications and variations. It is necessary to show that the combination has been appropriately designed and controlled and can be used correctly in the intended clinical situations, the paper said.
Drug companies making DDCs have been waiting for the guidance for some time now, none more so than those developing single, integral DDC products that are not reusable.
The MDR (2017/745) was adopted in April 2017 and comes into force in May 2020. It contains a provision called Article 117, which has introduced via an amendment to Europe’s key medicines directive (2001/83/EC) a new requirement for integral products (except for those that fall under the Class 1 non-sterile or non-measuring category). When the requirement kicks in in next year, marketing authorization applications for these products will have to start including an opinion by an EU-designated notified body on the conformity of the device component.
While the new requirement sounds simple enough, companies have been worried about it for some time now. (Also see "Find Your EU Notified Body Now Or Risk A ‘Nasty Surprise’" - Pink Sheet, 27 Nov, 2018.)
The first in a series of guidances on how to comply – a Q&A document from the EMA – was only released a few months ago, even though there has been pressure on companies long before then to get their house in order and find their notified bodies. (Also see "Advice At Last For Drug Makers Worried About New Medical Device Rules" - Pink Sheet, 4 Mar, 2019.)
According to Ritzhaupt, the new draft guidance will contain “clear instructions” on what to submit in a marketing dossier for integral and non-integral DDC products.
He added that the document would be issued for a three-month consultation period.