Last week’s round-up;
17 – 21 August 2020
EUDAMED- use of actor registration module and Single Registration Number (SRN)
The European database on medical devices (EUDAMED) is an IT system developed by the EC to implement the MDR. EUDAMED will consist of multiple electronic systems (so called ‘modules’) including an electronic system on registration of economic operators, also referred to as the actor registration module. The actor registration module allows for the creation of a unique single registration number (SRN) for the purpose of identifying the manufacturer, and where applicable the authorized representative and the importer. Full functionality of EUDAMED is delayed until 2022 however the Commission has confirmed its readiness to deploy the first module namely the actor registration module as of 1 December 2020.
The Medical Device Coordination Group (MDCG) position paper linked here https://bit.ly/32h2X5k strongly encourages the use of the actor registration module by all relevant actors in their territories including the use of SRN as stipulated in the MDR as of 1 December 2020.
Revised EMA guidance on pyrrolizidine alkaloids in herbal medicines
The EMA has revised its draft ‘Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination of herbal medicinal products with pyrrolizidine alkaloids’. Pyrrolizidine alkaloids are found naturally in some plants and several PAs are regarded as both hepatotoxic and carcinogenic. The document contains the EMA’s recommendations for the oral and cutaneous use of herbal medicinal products and traditional herbal medicinal products containing PAs. The guidance describes the chemical, toxicological, pharmacological and pharmacokinetic properties of these impurities.
Resuming UK on-site inspections – MHRA expectations
The MHRA intends to resume an on-site UK risk-based GxP inspection programme in September 2020, following a reduction in restrictions brought on by the COVID-19 pandemic. The Agency plans to scale up to a full programme as of October 2020. In view of this, the MHRA has released guidance for the industry to ensure that the on-site inspections are carried out safely and in accordance with the current government guidelines on COVID-19 mitigation. The guideline covers various aspects of GxP inspections including the necessary planning required prior to the inspection, guidance related to the conduct of the actual on-site inspection and also post-inspection guidance.
The full guideline may be viewed at the following link: https://bit.ly/RealCMC-3aHbyC7
ICHQ12: A European Perspective
The much-anticipated ICH guideline Q12, dealing with post-approval changes to chemistry, manufacturing and controls (CMC), has been released in its final version. However, in Europe this has come with a disappointing catch. It cannot be fully implemented due to the current EU legal framework. Our new article outlines the guideline’s main principles and highlights what can and cannot be implemented within the EU at this time.
Read it here: https://lnkd.in/eCHkdJE
MHRA Analytical QbD consultation
The MHRA has concluded its consultation on the application of Analytical Quality by Design (AQbD) principles to pharmacopoeial standards for medicines in collaboration with the industry. The Agency has identified the following four strategic objectives which will be delivered through a dedicated work programme:
• To develop and publish new standards and guidance.
• Further explore the application of AQbD concepts.
• Build capability across the Agency.
• Engage and collaborate with stakeholders.
Further information on the outcome of the MHRA consultation may be found at the following link: https://bit.ly/RealCMC-3aLi37j
MHRA Inspectorate Blog: Data on Serious Breaches of GCP
In 2019, MHRA received a total of 112 serious breach of GCP notifications, of which 75 were deemed to be a serious breach, 36 deemed not to be a serious breach, and 1 is yet to be resolved. MHRA has also just updated the associated notification form and guidance so that the quality and completeness of the submitted information is sufficient to allow full assessment and determination of the breach.
Full details can be found under this link: https://lnkd.in/dGedBWY
Possible impurity in paracetamol and CEP validity update
Paracetamol manufactured by a particular company holding a certificate of suitability was reported to be possibly contaminated with the mutagenic impurity 4-chloroaniline (PCA), a known impurity that may be formed during the manufacturing process of this active ingredient. However, an investigation carried out by the EDQM has shown that the levels of PCA in this active ingredient were well below the acceptable limits. Therefore, the CEP for paracetamol from the concerned manufacturer is still valid as the safety of the active ingredient has not been compromised.