Quality & use of medicines
Certification of suitability to the Ph. Eur. monographs
The Certification of suitability procedure was set up to evaluate and validate the capacity of Ph. Eur. standards to control the quality of substances used in the manufacture of medicinal products. It includes a programme for the inspection of manufacturing sites of active substances, and Certificates of suitability (CEPs) granted to manufacturers provide assurance to both industry and national authorities that their products are adequately controlled by the Ph. Eur. quality standards. CEPs are recognised by all EU states, as well as by Australia, Canada, Morocco, New Zealand, Singapore, South Africa and the World Health Organization, among others.
Significant steps in certification
RTEMIS inspections:
On-site inspections:
Desktop assessments:
New and revised CEPs granted
In 2023, the EDQM received 381 new CEP applications (–10% over 2022) and around 2 400 CEP revision requests (+9%). Some 442 new certificates (–4%) and 1 416 revised certificates (–8%) were issued, and processing times for new dossiers and revisions improved throughout the year. As of 31 December 2023, there were more than 6 310 valid CEPs covering chemical purity, transmissible spongiform encephalopathy (TSE) and herbal drug preparations.
CEPs suspended and/or withdrawn
In 2023, 19 CEPs were suspended and/or withdrawn, mainly after the respective CEP holders were unable to meet the requirements of the procedure for the maintenance of their dossiers, to address the presence of impurities, or due to good manufacturing practice (GMP) non-compliance. One CEP was suspended at the request of the holder. On the other hand, one CEP was restored after the company concerned took appropriate action in response to the suspension of their CEP.
Communication with Ph. Eur. groups of experts: requests for revision of monographs
In 2023, 41 requests for revision of Ph. Eur. monographs were submitted to the relevant Ph. Eur. groups of experts for consideration, mainly proposing the addition of specified impurities to the monograph’s transparency list, together with a suitable test method.
The EDQM inspection programme
The EDQM runs a GMP inspection programme for active substance manufacturers, conducting on-site and remote inspections and using regulatory reliance principles (“desktop assessments”). A total of 26 on-site inspections were performed in 2023. These were carried out exclusively in India until August 2023, when inspections in China resumed. The EDQM continued the Real-Time Remote Inspections (RTEMIS) programme for the remote supervision of GMP compliance of manufacturing sites. Two such inspections were carried out. The results obtained were satisfactory, both from a technical point of view and in terms of expected outcomes. Finally, the EDQM performed desktop assessments for 35 manufacturing sites by exchanging data with inspectorates from international partners.
International co-operation
Throughout 2023, the Certification Department continued to work closely with national competent authorities in Europe and beyond. This continued co-operation is crucial to ensuring consistency in the approaches applied for the assessment of quality information on active substances, as well as for GMP implementation. The Certification Department worked towards increasing global acceptance of CEPs by welcoming a delegation from the South Korean Ministry of Food and Drug Safety (MFDS).
In May 2023, the Certification Department took over the International API Inspection programme secretariat.
Communication with applicants, partners and stakeholders
From the “CEP of the future” to the implementation of the CEP 2.0
The CEP 2.0 (the new name of the “CEP of the future”) was officially launched in September 2023. This “new look” CEP and associated changes to the procedure were put in place to better meet the needs of stakeholders. The CEP 2.0 offers both enhanced user-friendliness and greater transparency of the information conveyed, without increasing the regulatory burden related to the revision of CEPs. For a while, CEPs in both “new look” and “hybrid look” formats will be issued. This is intended to ease the burden this change represents for all parties involved. “Old look” CEPs (granted before 1 September 2023) remain valid until they are revised.
Throughout the year, the EDQM communicated regularly via its website or in webinars on the changes this project introduces. Additional information has been introduced in the Certification database. More information is now also shared with authorities via the Authorities database.
Update of CEP guidelines
In 2023, the EDQM Certification Department published a number of new or updated guidelines.
CEP application forms were updated to collect unique identification numbers related to the organisations and their localisation and with a revised Holder’s Commitment annex reflecting the CEP holder’s responsibilities towards their customers.
As part of the implementation of the CEP 2.0, the EDQM published guidance documents on revised requirements for the CEP dossier and on electronic signatures. The latest updates are available on the EDQM’s CEP 2.0 information web page, with links to the Certification Policy Documents & Guidelines web page.
CEP stakeholders were invited, via a public consultation process, to comment on documents/guidelines issued by the EDQM within the framework of the procedure.
