Editorial
Dear Members,
As this is our first edition of Excipients Insight in 2022 and although slightly late (!), I would like to extend my best wishes to you for personal and professional success in the year ahead.
As this article reports, the Board has been busy mapping out our detailed objectives for the year in line with our Agenda 2025. Our guide has been ‘less is more’, the idea being that if we agree on fewer improvement activities and focus on thorough execution, this drive us closer to our long-term vision rather than working on multiple initiatives and making little overall progress in achieving our strategic goals. You’ll hear more about the specific objectives at the forthcoming catch-up on 24 March. Unusually, so we don’t lose time, we’ll start implementation before their official endorsement at the Annual General Assembly, now scheduled for 22 June, hopefully in Brussels.
This allows me to mention my one great wish for 2022... to finally meet again in person! The Secretariat are very busy planning the Assembly and Forum as a face-to-face event where we very much hope many of you can attend in person. We’re hoping that COVID restrictions will recede even further making this possible and will indeed be a great achievement for the year! It’s also IPEC Europe’s 30th anniversary so we can’t afford not to celebrate that in the best way we can.
And before I close, I’d like to mention one more thing we need to address this year...succession. Securing members to participate in task forces, committees and the more strategic roles on the Board is vital to the continued success of our Association. In the short term across our structure, we are facing a high degree of turnover, so please spread the word about IPEC Europe in your companies to see who might want to get involved. The Association cannot function without you and others, so your engagement in this task is very much appreciated .. as indeed is everything that you do! I leave you with that note of thanks and full of high hopes as we head towards Spring!
Best regards,
Frithjof Holtz
IPEC Europe Chair
Updates from IPEC Europe Board, draft 2022 Objectives
The IPEC Europe Board met virtually on 17 January to review the outcome of the Membership Survey conducted in November and December 2021, see dedicated article. On this basis, the Board designed focused objectives for 2022 including developing an IT platform to support the collaborative work of the IPEC Europe Committees and Task Forces and building a regulatory intelligence network to monitor the broader regulatory environment impacting excipients.
Also, the Board will investigate creative solutions to reactivate IPEC Europe’s focus on compendial matters.
The balance between user - pharmaceutical companies - and supplier - manufacturer and distributors of excipients - represented in the membership is important to IPEC Europe and the Board will target recruitment to maintain this equilibrium.
IPEC Europe Membership Survey
From mid-November to mid-December, IPEC Europe surveyed its members to ensure that the Association continues to represent members’ expectations and needs. The survey was addressed to 210 people actively involved in IPEC Europe’s activities either by being part of a Committee/Task force or by commenting/reviewing documents: 50 members replied to the survey. Although the level of participation was disappointing and did not allow to draw firm conclusions, it was still informative and a good reference for the Board. Respondents said they are highly satisfied with their IPEC Europe membereship and consider it good value for money. A strong majority values IPEC Europe’s membership of IPEC Federation and EXCiPACT and feels sufficiently informed about their activities. Also this survey confirmed that members agree that organsing activities via ad hoc task forces allows for great agility when respond to a burning issues. On compendial matters, respondents again confirmed their high interest but did not feel that a Committee needed to be created. Again, working issues through task force is considered more appropriate. The outcome will be presented at the first quarterly IPEC Catch-up on 24 March (see dedicated article).
QRAC (Quality & Regulatory Affairs Committee) – EtO and IQ Consortium
Quality and Regulatory Affairs Committee
The Quality and Regulatory Affairs Committee met on 16 December and 17 February to define the objectives of the year such as contribution to IPEC Federation guides, initiatives on comparison of food/excipient standards, auxiliary materials, establishment of a process to identify upcoming regulations, and the respective deliverables.
Discussions are ongoing to re-structure the committee into Quality and Regulatory GMP teams, which if it goes aahead will require noiminees for the ‘leader’ roles. A poll on preferences for new committee designs will be shared with the Membership in the coming weeks.
The IPEC Federation Nitrosamines position paper is in its final stages and, pending approval from the IPEC Federation Board, will be published in the coming weeks. Thnaks to the greta contributions form the IE team! A similar outlook is foreseen for the comprehensive ‘How to’ document on Microplastics. When published, the regulations may change but meanwhile, this useful ‘aide memoire’ will inform Members of the requirements of the draft ECHA regulations allowing for some preparedness activites make ready for compliance.
The Co-processed excipients TF (Task Force) developed a narrative-presentation on current regulatory issues with this type of excipient; a letter was sent to EMA requesting a meeting on this important issue.
On regulatory activities, the evolution of the ban of titanium dioxide as a food additive is being closely monitored, and opportunities to collaborate with other associations on impact and alternatives are beign progressed.
An informative document on Ethylene Oxide is being prepared (see dedicated article).
Highlights of the meeting are available in the Member’s Lab.
Members of the QRAC Core Team will reunite on 11 May in hybrid (Brussels/MS Teams) format.
Ethylene Oxide (EtO)
A first meeting of IE members interested in Ethylene Oxide (EtO) took place on 27 January to discuss and evaluate whether the situation arising in food in Europe may develop and impact pharmaceutical excipients.
Since September 2020, the European Rapid Alert System for Food and Feed (RASFF) system has reported numerous cases of diverse food products exceeding the maximum residue limits (MRLs) for EtO; the European Commission established a “Zero tolerance” approach, which lead to the recall of various products from the market, even when no EtO can be detected on the final product but when one of the ingredients was found to be non-compliant.
EtO is being used as the starting material for certain pharmaceutical excipients and is allowed under certain condition for sterilisation of pharmaceutical products. Specific limits may be available thorough pharmacopoeial monographs and when available, these should be followed. Despite this, members have received requests from customers to guarantee lower/no contamination with EtO for each batch of product.
The group is planning to develop a summary for IPEC Members on the current situation in food that explains that there is currently no impact on pharmaceutical use.
Titanium Dioxide (TiO2) - IQ Consortium
The European Union formally banned E171 Titanium Dioxide from the list of authorised food additives as colorant with a transition period of six months. TiO2 remains approved as a pharmaceutical excipient, pending a further review by EMA by April 2024. The IPEC Europe Task Force has reconvened and is holding monthly teleconferences to exchange information on the latest global developments and gather data to support the continued use of TiO2 as a pharmaceutical excipient. To this end, IPEC Europe is collaborating with other organisations such as APV and the US-based IQ Consortium. The potential ban of TiO2 in Pharma could have broad impact including on the availability of medicines for patients. To date there is no other ingredient that can fully replace TiO2 ‘like for like’ i.e. provide equivalent opacity, will potential consequences for the stability of medicinal products. More recent notices on TiO2 reviews in Korea and Switzerland were highlighted.
IPEC Europe Excipients Forum to be held in Brussels in late June
SAVE THE DATE: IPEC Europe is delighted to announce that the IPEC Europe Forum is back, and will take place as a face-to-face event in Brussels, on 22-23 June 2022! Our eagerly-awaited Forum will be an opportunity to celebrate IPEC Europe’s 30th Anniversary and the 10th Anniversary of the start of EXCiPACT operations. We look forward to marking this occasion and recognising IPEC Europe’s many accomplishments with past and present Members alike.
Please keep a close eye on our website and LinkedIn page for more details.
Webinar – IPEC Safety Guide
IPEC Europe held its first webinar of the year on 24 February, covering the recently published IPEC Safety Guide for Pharmaceutical Excipients.
This IPEC Federation-branded online event was delivered by Dr. Stefan Schulte, Director, Regulatory Toxicology, Product Safety, BASF and Dr. Claas Gronewold, Regulatory Affairs Pharma Polymers, Evonik Nutrition and Care GmbH, who were also leading contributors from IPEC Europe to the development and finalisation of the Guide.
The presenters provided an overview on the Safety Guide, and explored the challenges for Novel Excipient Use; this was followed by an overview of Excipient Safety and Special Considerations and Alternatives.
The Q&A session sparked an interesting and lively debate, moderated by IPEC Europe Senior Advisor Adrian Bone.
Review the presentation and access the slide deck here: Webinar - IPEC Best Practices Guide for the Safety Evaluation of Pharmaceutical Excipients
IPEC Europe Excipient Conference 2022
The IPEC Europe Excipient Conference, organised in cooperation with APV GmbH, will take place on 27-28 September in Frankfurt am Main, Germany. IPEC Europe and APV have jointly developed a programme covering current “hot topics” in the field of pharmaceutical excipients, including topics such as 3D printing in Drug Delivery, and Transportation conditions for Excipients.
Further information can be found on the dedicated page of our website.
Making Pharmaceuticals
Mark your calendars! On 26-27 April 2022, Making Pharmaceuticals will be back in Coventry, UK. Making Pharmaceuticals will host over 2,000 visiting pharma professionals and more than 200+ exhibitors in six exhibition zones.
Our presentations featuring in the conference this year are:
- Excipient Sustainability : A User and Supplier’s Perspective, Dr Iain Moore, Head of Global Quality Assurance, Croda International
- Best Practices Guide for the Safety Evaluation of “Novel” Pharmaceutical Excipients with Reference to the IPEC Safety Guide, A Bone, Senior Advisor IPEC Europe
- Excipient Selection for Paediatric Medicines Using a Risk/Benefit Approach, K Hughes, Regulatory Affairs and QA Manager, Colorcon
Register for free to the Expo and conference: Making Pharma - Register now
IPEC Europe Catch-up - Q1
Registration is open for the first catch-up of 2022 on IPEC Europe Activities (24 March). This one-hour meeting is a great opportunity for all Members to get an update on what’s happening in the asscoiation. Introduced last year, these live events also provide an opportunity to interact with the Board and Committee/Task Forces leaders in a relaxed environamnt. Feel free to put up your hand and aks away!
The March Agenda includes the proposed objectives of the IPEC Europe Board, Quality & Regulatory and Good Distribution Practices Committees.
Please click here to register to the catch-up.
The recording and the slide deck will be made available after the event to all Members in our Member’s Lab.
IPEC Europe's reply to EMA survey on Quality Innovation Group
The European Medicines Agency (EMA) issued a survey to stakeholders to identify the top priorities of its future expert Quality Innovation Group (QIG). Prior to establishing the QIG, EMA wishes to take stock of the current status of CMC innovation in Europe. The output of this survey will complement the feedback gathered in preparation of the Regulatory Science to 2025 strategic reflection, identify any subsequent developments, and inform the expertise requirements for the QIG membership. While largely directed at pharmaceutical companies, Section 6 focuses on which Novel Materials, previously unused in medicinal products, are being developed to manufacture them in the next 5-10 years. EMA asks what are the potential barriers in the legislation or current guidance that could slow down or prevent their introduction. And equally, what would be needed in the legislation or current guidance to facilitate the introduction of these new materials.
This survey presents a great opportuntiy for IPEC Europe to restate its positions on how advanced drug delivery platforms for new drug therapies create a need for novel excipients / using established excipients differently. As we know, the use of novel excipients is inhibited because of the lack of globally harmonized definition for them, safety data requirements are not transparent and the associated intellectual property does not have the same protection as APIs. The broader use of co-processed excipents is also discouraged by differing regulatory interpretations of their status, a point made in the comments submitted.
Of course, the need for legislation to allow for an excipient master file system in the EU to facilitate the use of novel or modified excipients was well made. As would harmonized guidance for the safety assessment of novel excipients, improving transparency on how to introduce novel excipients.
The submission to EMA is available in the Member’s Lab, under Members / Submissions to public consultations.
EDQM: free-to-attend webinar, PharmEuropa 34.1
Webinar - Getting the big picture: what has changed in the Ph. Eur. General Notices
The European Pharmacopoeia (Ph. Eur.) General Notices provide users with a basic understanding of Ph. Eur. texts and how to use them: reading them is the essential first step before applying any monograph or general chapter.
As of Supplement 10.7, the Ph. Eur. General Notices have been extensively revised to clarify and/or amend terms and concepts, and to add a section on medicinal products containing chemically defined active substances.
This webinar is intended as a refresher course on the concepts in use, but also emphasises the main changes brought to the General Notices.
The webinar will take place on 7 April 2022, from 2:00 p.m. to 3:15 p.m. (CEST).
A live Q&A session will follow the presentation.
Participation is free of charge. To register, please click here.
EDQM
PharmEuropa 34.1
The latest issue of Pharmeuropa 34.1 contains 48 drafts published for review and comments. The full list is available here. The deadline for comments is 31 March 2022. If any IPEC Europe members would like to convene an interest group to discuss changes to any excipient monographs, please let the IPEC Europe Secretariat know
Recommended readings
A stronger role for EMA
Published on 31 January 2022, Regulation 2022/123 sets out a stronger role for EMA in managing public health crises, and aims to formalise the ad-hoc structures and processes that have been used by EMA during the COVID-19 pandemic. The intention is that these ad hoc process can now serve as a blueprint for a more harmonised EU response to future public health emergencies.
European Medicines Agency
European medicines regulatory network adopts EU common standard for electronic product information
The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information (ePI) on medicines in the European Union (EU). This will pave the way for wider dissemination of unbiased, up-to-date information on all medicines available to patients in the EU through an ever-expanding range of electronic channels.
European Medicines Agency
Final Annex 21 published
The final version of Annex 21 to the EU-GMP Guidelines ("Importation of medicinal products") has been published in EudraLex Vol. 4. The draft was already published for comments in March 2020. Approximately 200 comments were received from 17 stakeholder organisations. The new Annex will come into operation on 21 August 2022.
ECA
ICH: Leaflet
ICH is pleased to announce the publication of a Leaflet on ICH. This leaflet provides a brief overview of ICH’s mission, structure, and current work. Details on ICH can be found in the ICH 30th Anniversary publication available here.
For more information, please click here
ICH
Calendar
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Group
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2022
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IPEC Europe Board
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17 January
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Good Distribution Practices Committee
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late March
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Quality & Regulatory Affairs Committee
(Core Group)
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11 May
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| Co-processed Excipients Task Force |
TBA |
| Microplastics Task Force |
15 March |
| Titanium Dioxide Task Force |
16 March |
| IPEC Europe Catch-up - Q1 |
24 March - Register now |
All meetings will be held online unless mentioned otherwise.
Do you wish to join a Committee or a Task Force? Please contact the IPEC Europe Secretariat! We will connect you with the Head/Chair of the group.
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