Now that we have wrapped up the year 2020, it’s important to look ahead and prepare for upcoming regulatory deadlines. It is essential to address these changes and develop a plan, albeit nimble as 2020 taught us, because preparedness is key to success. This blog will explore some of the key themes to kick start your year.
EMA and FDA Requirements for Control of Nitrosamine Impurities
Both EMA and FDA are requiring that all human medicines, irrespective of the marketing status, are assessed for the possible presence of nitrosamines as of September 2020. FDA requires the completion of a risk assessment for chemical products by February 28, 2021 and EMA by 31 March 2021, with EMA providing an additional three months for biological products.
The Immediate Scope
- Both EMA and FDA require completion of the risk assessment for chemical products in the first quarter of 2020
- Both EMA and FDA recommend that the effort to develop confirmatory testing should immediately be undertaken for products designated as high risk, by the manufacturer of newly filed, approved, or marketed products.
The Long-Term Scope
- EMA and FDA currently require the control of nitrosamine impurities at acceptably low levels in chemical products, by September 2022 and September 2023, respectively, with EMA providing an additional nine (9) months for biological products (by July 1, 2023). To achieve this, manufacturers will be required to perform confirmatory testing of their drug products at risk and submit to the applicable regulatory authorities, revisions to drug applications that may be required to control nitrosamine impurities.
If you need support to meet nitrosamine regulatory requirements, contact ProPharma Group. With a global team of experts, ProPharma Group has the expertise essential to satisfy these new demands. Through close collaboration with your team, we will ensure control of nitrosamine impurities in medicinal products for human use.
Learn more on executing a successful risk assessment by downloading our case study.
Brexit
Late December the EU and the UK reached a trade agreement covering key aspects of Brexit. This agreement that came into effect on January 1st, 2021, explains the effects on trade as the UK is now classified as a “third world country”. For pharmaceuticals, the main aim of the principles in the agreement is to serve in the best interest of patients in both the UK and the EU preventing unnecessary duplication and costs.
Collaboration between the UK and the EU in areas such as scientific research and medicine safety will remain a priority. The biggest change will be the border and custom arrangement to limit the interruptions of medicine supply to both regions.
A significant achievement was the notion that inspections of medicines conducted in either the UK or the EU, will be considered valid in the other to prevent separate inspections. Whether this applies to quality and safety tests remains unclear, as no specifications were included on the validity of batch tests.
Click here to learn more about the impacts of the Brexit transition.
EudraLex Volume 4, Annex 1 Update
EudraLex Volume 4, Annex 1 provides guidance for the manufacture of sterile medicinal products that are intended for the European market. It has been updated several times with the latest revision in 2008, but a major, fundamental revision has not been carried out until now.
The objective of the upcoming revision is to add clarity, introduce the principles of Quality Risk Management, allow for the inclusion of new technologies and innovative processes, and change the structure to a more logical flow. We anticipate the revised EU GMP Annex 1 will be published in 2021, and will share updates as they become.
So, what are your next steps? The best way to implement the new version of Annex 1 may be to start with a high-level gap assessment to identify potential contamination risks that are not yet covered by a QRM approach. The next step would be setting up the required CCS, thereby assessing newly identified and re-assessing known contamination risks as well as assessing compliance with the Annex.
For newly identified contamination risks, appropriate control measures and monitoring systems should be designed and implemented while the control and monitoring of known contamination risks should be verified for meeting the expectations in accordance with Annex 1.
To learn more, click here for a comprehensive guide to the update.
