◆ Consultation on draft guideline on quality requirements for medical devices in combination products (03-Jun-19 EMA)
EMA has released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month public consultation.
The guideline addresses the new obligations in Regulation (EU) 2017/745 on medical devices, in particular the requirements under Article 117. This article foresees that the marketing authorisation application should include a CE (Conformité Européenne) certificate or declaration of conformity for the device or, in certain cases, an opinion from a notified body (NB) on the conformity of the device.
The guideline covers devices that are necessary for the administration, dosing or use of the medicine. They can be integral, co-packaged or referred to in the product information of the medicine but obtained separately. It specifies which information about the device needs to be submitted as part of the initial marketing authorisation application and subsequently during the product lifecycle. It also contains a proposed template for the NB opinion on the conformity of the device to the relevant general safety and performance requirements laid down in Regulation (EU) 2017/745.
It is intended that this guideline will increase transparency and consistency of information in regulatory submissions, reducing work for all stakeholders and ultimately improving patient safety.
Stakeholders are invited to send their comments by 31 August 2019 to qwp@ema.europa.eu using the template provided.
EMA will take into account comments received during the consultation, with a view to finalising the guideline before the regulation fully applies on 26 May 2020.
◆ Revised USP Chapter <1226> Verification of Compendial Procedures (05-Jul-19 ECA)
The revised USP general chapter <1226> VERIFICATION OF COMPENDIAL PROCEDURES has been approved for USP42-NF37, second supplement. The draft chapter was published for comment in Pharmacopeial Forum PF 44(3) [May-June 2018].
The second supplement to USP 42–NF 37 will be released in June 2019 and will become official on December 1, 2019. According to the draft the revised general chapter <1226> will introduce changes under “verification requirements” to indicate that the stability of solutions used for testing needs to be evaluated during the verification of the procedure (“It is the user’s responsibility to demonstrate the stability of standard and sample preparations throughout the duration of the procedure”).
However, if the verification of the compendial procedure is not successful, it may be concluded that the procedure may not be suitable for use with the article being tested. It may then be necessary to develop and validate an alternative method as allowed in USP´s General Notices, 6.30 Alternative and Harmonized Methods and Procedures. Furthermore, the alternative procedure may be submitted to USP, along with the appropriate data, to support a proposal for inclusion or replacement of the current compendial procedure.
More detailed Information can be found in the USP general chapter <1226> Verification of Compendial Procedures.
◆ Serialisation: New Guidance for EU Inspectors (03-Jul-19 EMA)
Back in 2011, the European Commission (EC) published Directive 2011/62/EC, the so-called Falsified Medicines Directive (FMD).The main goal was to support the fight against counterfeit medicines. The new Directive had quite some influence on the pharmaceutical supply chain. It further introduced numerous Delegated Acts requiring certain safety features (Unique Identifier and Anti-Tampering Device), had some impact on revisions of several chapters of the EU-GMP Guidelines and led to a complete revision of the EU-GDP Guidelines.
In 2016, Commission Delegated Regulation (EU) 2016/161 was officially published, laying down detailed rules for the safety features and coming into force on 9 February 2019. GMP inspectors started looking thoroughly into the implementation during their site inspections. Now, The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the regulation.
Questions listed in the document focus for example on:
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