PharmaCompass is introducing a new regulatory update
that tracks developments in Certificates of Suitability to the Monographs of
the European Pharmacopoeia, referred to as CEPs. These certificates are a
critical regulatory instrument in the global pharmaceutical supply chain.Also known as a
Certification of Suitability (COS), CEPs are issued by the European Directorate
for the Quality of Medicines and HealthCare (EDQM), with or without inspection
of the manufacturing site. A CEP must be renewed every five years from its original issue date to remain
valid, regardless of any revisions made during the interim period. However, a
CEP does not replace Good Manufacturing Practice certification.CEPs are recognized as a trusted
reference for API quality, thereby simplifying global registration strategies. Apart from Europe, the CEP
system is widely used by many regulatory authorities, including those in Canada, Australia, Brazil, Singapore
and South Africa. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)CEP 2.0 enhances regulatory clarity, brings efficiency, global interoperability There are several types of CEPs, depending on the nature of the
substance and evaluation. The most common type is the Chemical CEP, which
confirms that a chemically synthesized API meets standards for purity and
impurity control. Then there are Herbal CEPs for herbal substances and
preparations.Another key category is the TSE CEP, which addresses risks associated with transmissible spongiform encephalopathies in animal-derived materials. In addition, there are Combined CEPs that may cover multiple aspects, such as chemical quality, TSE risk, and sterility. However, biological products such as vaccines and blood products fall outside the scope of the CEP framework.In
2023, the CEP system underwent a major transformation with the introduction of CEP 2.0,
which marks a shift from a largely document-based system to a more structured,
transparent, and digitally aligned model. This makes it easier for companies to manage compliance while
improving trust among global regulators.While increasing data and compliance
requirements for API manufacturers, CEP 2.0 enables better regulatory clarity,
streamlined dossier integration, and stronger global acceptance. Overall, CEP 2.0 is designed to enhance regulatory clarity while making the system more efficient and globally interoperable. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)Indian
firms issued maximum CEPs; Sun Pharma and its subsidiaries, Jubilant Biosys top
listIndia topped the
charts for CEPs issued, both in terms of new CEPs and revisions in the first
quarter (Q1) of 2026. Indian companies were issued 81 new CEPs in Q1 2026 (as
against 40 in Q1 2025) and 203 revisions (as against 129 in Q1 2025). In
comparison, Chinese companies were issued 42 new CEPs in Q1 2026 (against 25 in
Q1 2025) and 53 revisions (against 67 in Q1 2025). Italy came a distant third,
followed by Germany and Spain.India’s Sun Pharmaceuticals and its subsidiaries topped the list of companies with the maximum number of CEPs issued— while no new CEP was issued, 27 CEPs were revised in Q1 2026. At second place was Jubilant Biosys — 21 CEPs were revised in Q1 2026.In terms of
products, the maximum CEPs were issued for amlodipine besylate (a calcium channel blocker used for
treating hypertension), followed by sitagliptin phosphate (a type 2 diabetes medicine) and pregabalin (a drug used to treat neuropathic pain,
fibromyalgia, seizures, and generalized anxiety disorder). Both amlodipine
besylate and sitagliptin phosphate had not been issued new CEPs or revisions in
Q1 2025. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)EDQM introduces new guidelines to accelerate CEP assessments The EDQM charges fees for various services related to CEPs
that depend on the type of request or regulatory activity involved. In general,
fees apply to handling CEP applications,
revisions or renewals and for offering technical advice (where applicants seek
scientific or regulatory guidance).In
March 2026, the EDQM introduced two new guidelines aimed at accelerating CEP assessments. The first is a reliance-based assessment pathway, which allows regulators to leverage prior approvals from trusted authorities, such as those in the EU, UK, Australia, Canada, and the WHO pre-qualification program. The second is a fast-track assessment route designed to expedite reviews in situations such as medicine shortages and to support initiatives like the EU Critical Medicines Act.Timelines have been significantly compressed under these new pathways.
Initial evaluations are
completed within 46 working days, compared to up to 115 days under the standard
procedure. Applicants are given 30 calendar days to respond to queries, after
which regulators complete the final assessment within 23 working days.Another
important regulatory update relates to electronic submissions. From April 1, 2026, the EDQM
will reject non-compliant CEP applications at the point of submission. All
applications must include a validated electronic Common Technical Document
(eCTD) dossier along with a proper validation report, submitted in line with
the updated Common European Submission Portal (CESP) guidelines. Taken
together, these developments signal a more rigorous yet efficient CEP
ecosystem. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)Our viewThe shift to CEP 2.0 signals a move toward greater transparency, digitalization, and global regulatory alignment. Though enhanced disclosure and stricter e-submission requirements may increase the compliance burden, especially for smaller manufacturers, the long-term gains are expected to be significant. Going forward, companies that invest in data quality and regulatory readiness stand to gain from these changes.
Share
