Last week’s round -up;
26-30 July 2021
EMA issues new draft guidance on core SmPC, labelling and package leaflet for ATMPS
EMA has opened up a consultation from 30th July 2021 through to 31st of Oct 2021 on a new guidance for ATMPS containing genetically modified cells. The guideline seeks to describe the information to be included in the summary of products characteristics (SmPC), labelling and package leaflet and it is intended to apply to allogeneic or autologous, including viral vector modified and genome edited cells. Examples for Chimeric Antigen Receptor T (CAR-T) cells and Cluster of Differentiation 34+ (CD34+) modified cells are given in more detail. These can be used as model wording for other types of genetically modified cells.
The draft guidance can be found here: https://lnkd.in/e8rPmDr
New ICH Q13 continuous manufacturing guideline
The ICH has released a new draft ICH Q13 guideline on continuous manufacturing of drug substances and drug products, which is open for public consultation. The new draft ICH Q13 consists of a main guideline and five annexes. The main guideline covers three different models of continuous manufacturing, and reviews control strategy and regulatory considerations. The three models of continuous manufacturing covered by the guideline include: 1. A combination of approaches in which some unit operations operate in a batch mode while others operate in a continuous mode 2. A model where all unit operations of a drug substance or drug product manufacturing processes are integrated and operate in a continuous mode 3. An approach in which the drug substance and drug product unit operations are integrated across the boundary between drug substance and drug product to form a single continuous manufacturing process. The annexes cover continuous manufacturing of drug substances, as well as continuous manufacturing of drug products, therapeutic protein drug substances, integrated drug substances and drug products and perspectives for managing disturbances.
https://bit.ly/RealCMC-3rGnsoB
Attention CEP Holders: New Draft Ph. Eur. Monographs
The following fifteen draft Ph. Eur. monographs, for which CEPs have been granted, have been published in Pharmeuropa 33.3:
• Amylmetacresol
• Calcium acetate
• Calcium ascorbate
• Cholecalciferol
• Clodronate disodium tetrahydrate
• Diclazuril for veterinary use
• Estriol
• Isoniazid
• Ondansetron hydrochloride dihydrate
• Pemetrexed disodium heptahydrate
• Propylthiouracil
• Raltegravir potassium
• RRR-alpha-Tocopheryl acetate
• Thiamine nitrate
• Tibolone
The EDQM has therefore asked CEP holders to consult the list of substances and provide feedback on the draft monographs before the 30th September 2021.
https://bit.ly/RealCMC-3iaoC8z
EMA issues new guidance on quality documentation required for medicinal products when used with a medical device
The EMA has finally issued new guidance that focuses on product-specific quality aspects of a medical device, or device part, that may have an impact on the quality, safety and/or efficacy (and hence overall benefit/risk determination) of a medicinal product.
The guidance covers; Medicinal products where the medical device and/or device part form an integral product that is not reusable; Medicinal products that are co-packaged with a device; Medicinal products that are required to be used with a specific medical device.
The guidance which is effective from 1st Jan2022, can be found here :
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-documentation-medicinal-products-when-used-medical-device-first-version_en.pdf
EMA has updated pre-authorisation guidance for users of the centralised procedure
By the end of September 2021 any new sites and organisations to be registered for a Medicinal Product Marketing Authorisation will have to have to be registered in the EMA’s Organisation Management Service (OMS). This will be mandatory and EMA is keen to stress the importance of this site registration before the regulatory submission in order to avoid any delay in the start of the MAA process. If not applicants will be requested to register the site(s)/organisations during validation and prior to the start of the procedure. The guidance now also give detail instructions on the withdrawal of a request for submission of an MAA to EMA, if the applicant no longer wishes to submit an MAA.
The latest document with full details of the pre-submission guidance from EMA can be found here: https://lnkd.in/g5YcXxj
Upcoming ICH Analytical Guidelines
The ICH intends to release two new guidelines, ICH Q14 and ICH Q2(R2), which should allow manufacturers to switch analytical methods for testing medicines post-approval more easily and allow for better lifecycle management. The upcoming ICH Q14 guideline will harmonize scientific approaches to analytical procedure development to allow for a more efficient, sound scientific and risk-based approval. The ICH Q2(R2) guideline will replace the current ICH Q2(R1) guideline and will include some of the newer analytical procedures. Together the two forthcoming ICH guidelines should create a harmonized performance-based approach for allowing analytical method changes. The new ICH guidelines should be available for public consultation in December 2021.
https://bit.ly/RealCMC-3y8O3wU
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Last weeks round-up; 28 October – 1 November 2019
MHRA GMDP SYMPOSIUM 11-12 November 2019
We’re excited to be discussing the latest updates on guidance and increasing complexity in the manufacturing and distribution chain requirements with our peers at the MHRA GMP & GDP Symposium in London, 11-12 Nov. If you’re also attending, get in touch! Our QMS and regulatory affairs compliance expert Niamh Miller would love to see you there! Contact us to arrange a meeting: https://lnkd.in/daQjxxj
RECOMMENDATIONS ON SUBMISSION DATES IN 2020 FOR DCP AND MRP Procedures
HMA-CMDh has just issued their annual recommendation on submissions dates for DCP and MRP for 2020. Check out the individual links below for details ⬇️⬇️
Recommendations on submission dates in 2020 for applicants of the DCP: https://www.hma.eu/92.html
Recommendations on submission dates in 2020 for applicants of the MRP: https://www.hma.eu/93.html
EMA ISSUES NITROSAMINE IMPURITIES OVERVIEW
EMA has issued an overview to advise companies on steps to take to avoid nitrosamines in human medicines. This includes templates, published 28th Oct 2019, for responses to EMA following Step 1: Risk evaluation and Step 2: Perform further confirmatory testing. Further details can be found on the EMA website here: https://lnkd.in/d9T22zp
EUROPEAN COMMISSION: GMO REQUIREMENTS FOR ATMPS IN CLINICAL TRIALS
A Good Practice document on the assessment of GMO related aspects in clinical trials with AAV clinical vectors has been developed by the national competent authorities & the Commission services. It builds on possibilities under the existing legislation to facilitate the conduct of clinical trials with ATMPS and has been endorsed by Austria, Belgium, Croatia, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Luxembourg, Netherlands, Portugal, Romania & Spain.
Developers that intend to conduct a trial in these countries can follow the approach laid down here: https://lnkd.in/ey2NfV9
In addition, a common application form for investigational medicinal products for human use that contain or consist of AAV vectors has been endorsed by the above Member States: https://lnkd.in/eCmCCEE
EMA DIALOGUE WITH CHINESE AUTHORITIES ON MEDICINES REGULATION
The Deputy Commissioner of the Chinese National Medical Product Administration (NMPA) visited EMA on 25 October together with a delegation. The visit took place in the context of the ongoing EU-China regulatory dialogue on pharmaceuticals. Topics for discussion included GMP standards for active pharmaceutical ingredients, GCP standards, and the Commission’s strategic approach to pharmaceuticals in the environment. Further discussion can be found here https://lnkd.in/eYr5dBK
Last weeks round-up; 14 – 18 October 2019
EVALUATION OF THE EU BLOOD, TISSUE AND CELLS LEGISLATION
On 11 October 2019, the European Commission published its evaluation of the EU blood, tissues and cells legislation. An executive summary is also available. This was the first evaluation of the legislation since the adoption of the basic Acts in 2002 (blood) and 2004 (tissues and cells). Further information and a link to the evaluation can be found under this link https://lnkd.in/ds48XHY. The results of the evaluation will be disseminated at a Conference in Brussels on 28 October 2019.
EMA: UPDATED VERSIONS OF eAFs NOW AVAILABLE
EMA has just issued version 1.23.1.3 of the 4 electronic Application Forms (eAF), which are now available on the eAF website, along with new release notes and a release milestone plan. This release is a bug fix release to correct a number of issues which affect the forms. The bug fix release does not affect the Data Exchange Standard (DES). Applicants are reminded that the version of the form should not be changed during an ongoing procedure. https://lnkd.in/de7AFKu
PAEDIATRIC COMMITTEE (PDCO) MEETING MINUTES
An overview of Pedmed-NL (the former Dutch Medicines for Children Research Network) was presented. The network has been involved in the development of the Dutch Paediatric Formulary (kinderformularium), the establishment of European Paediatric Translational Research Infrastructure (EPTRI) and Paediatric Clinical Research Infrastructure (PEDCRIN) as well as in the planning of clinical trials, mainly via Connect4Children (C4C). The network was relaunched in 2018 as PedmedNL with main goal to facilitate and support the conduct of C4C proof of viability studies (by 2023). The main goal beyond 2023 is to create a sustainable network for research in children. The minutes can be found under; https://lnkd.in/dpNCPqQ
UK WITHDRAWAL FROM EU: EMA RELOCATION TO AMSTERDAM
EMA has recently reported a further 6% reduction in workforce as a result of relocating to Amsterdam. As a result EMA is reviewing its organisational structure and looking to set up task forces that will focus on key priorities for the European medicines regulatory network further details can be found here: https://lnkd.in/dx49VpY
EMA ADVISES COMPANIES ON STEPS TO TAKE TO AVOID NITROSAMINES IN HUMAN MEDICINES *UPDATE*
As previously advised, EMA has requested all EU marketing authorisation holders of medicinal products containing chemically synthesised APIs to review their medicines within the next 6 months for the presence of nitrosamines. Real Regulatory has both the expertise and resource to support this review process. For more information on the EMA recommendation, including a Q&A quide: https://lnkd.in/erne7TZ
EMA PRIME ELIGIBILITY REQUESTS
EMA has just published its deadlines and timetable for PRIME Eligibility request assessments for 2020. Further details can be found here; https://lnkd.in/d7Z8x6J
