Latest in Regulatory

Why the IVDR preapplication process matters for legacy manufacturers

For many in vitro diagnostic device (IVD) manufacturers, the first direct interaction with regulators comes through a Notified Body (NB) under Regulation (EU) 2017/746 (IVDR). Understanding the NB’s role, responsibilities and processes is essential … especially for legacy manufacturers transitioning from pre-IVDR certifications

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Bioprinting in cancer treatment: improving models, accelerating drug development and overcoming research challenges

As global cancer diagnoses increase — projected to reach 35 million new cases annually by 2040 — the need for more effective and economically sustainable oncology therapies...
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FDA to get foreign manufacturing inspections "back on track" with new inspection scheme

The inspection scheme means that foreign pharmaceutical and medical product manufacturers will be subject to unannounced inspections by the US regulator

DFE Pharma achieves ISO 22301 certification for BCMS

DFE Pharma's Business Continuity Management System (BCMS) at its head office in Goch, Germany helps it to effectively maintain its operations

European Pharmacopoeia Commission details HTS methods for biologics testing

The new chapter lays out high-throughput sequencing methodologies, assisting biopharma and biotech companies in implementing the technology

Biomay bags FDA approval for the manufacture of recombinant Cas9 nuclease

The company's Cas9 nuclease can now be commercialised in the key US biopharmaceutical market, and is an essential part of CRISPR-based gene editing therapies

WHO pandemic agreement determined after three years of negotiation

Through the deal, WHO will promote a unified, global response to future pandemics, ensuring that national health systems are equipped to control future outbreaks

Common reasons why field certifiers fail accreditation

Biosafety cabinets are the backbone of laboratory safety; however, many facilities encounter significant obstacles when using them, such as high energy consumption, difficulties with decontamination and inefficient filter replacement processes
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Why PMS is about more than just compliance

Post-market surveillance (PMS) covers a range of measures to monitor the safety of a drug or medical device after it has been released for sale

Optimising early-stage drug development with continuous processing

Pharmaceutical innovators face many challenges when developing new products; as such, getting them to market in a timely, safe and cost-effective way is critical. The use of continuous manufacturing technologies can help to overcome some of the most pressing early-stage obstacles

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ICH E6(R3) guidelines call for a new approach to sponsor oversight

The ICH E6(R3) guidelines, effective July 2025, mandate a proactive data-driven approach to sponsor oversight, focusing on maintaining essential records in digital clinical trials. Sponsors must modernise their record-keeping and oversight tools to ensure compliance and integrity

Shilpa Pharma Lifesciences' API manufacturing site passes FDA inspection

This is the second inspection the CDMO's unit-2 API manufacturing facility in Raichur, India has passed

Sanofi's BTK inhibitor rilzabrutinib granted FDA orphan drug designation

Rilzabrutinib has already received orphan drug designation from the EU and Japan for use in patients with immune thrombocytopenia

Quality and compliance: the foundation of trust

As the CEO of Symbiosis, a contract manufacturing organisation (CMO) licenced to manufacture sterile medicinal products, Colin MacKay understands the profound responsibility involved in ensuring that the products they manufacture meet the highest quality standards and adhere to all relevant regulatory requirements

4basebio attains UK GMP certification for large-scale synthetic DNA production

Through this MHRA approval, 4basebio will be able to provide GMP-grade synthetic DNA for use by pharmaceutical companies and researchers in clinical programmes

CARBOGEN AMCIS secures GMP certification after successful ANSM inspection for its aseptic drug product manufacturing site

This is the first inspection of a routine process by ANSM to ensure compliance with Good Manufacturing Practices (GMP)

Trump's pharma tariffs to be introduced "in the near future"

President Donald Trump has announced that he will be introducing tariffs to pharmaceutical imports in the "very near future", though it's unclear if this will begin on April 2 as previously thought
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Forecasting the future of peptide manufacturing: CMC challenges in the GLP-1 era

In this article, Torsten Wöhr, Chief Commercial Officer at Bachem, explores the future of peptide CMC manufacturing for GLP-1 therapies, including innovations in sustainable peptide production, purification and compliance
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Extractables and leachables: avoiding compliance bottlenecks to meet regulatory expectations

As single-use systems (SUSs) transform the pharmaceutical manufacturing landscape, their growing prevalence has introduced unprecedented opportunities and challenges

AskBio's Parkinson's gene therapy, AB-1005, receives FDA RMAT designation

The Bayer subsidiary is currently recruiting for the Phase II REGENERATE-PD trial, which will assess AB-1005's potential in slowing Parkinson's disease progression and improving motor outcomes

Indena becomes first API manufacturer to receive European CEP certification

Its CBD extract is the first to receive the European Pharmacopoeia Certificate of Eligibility from the European Directorate for the Quality of Medicines (EDQM)

Sanofi's Novolog biosimilar Merilog gets the FDA green light

The biosimilar improves glycaemic control in diabetic patients by lowering blood sugar spikes, and is the first fast-acting insulin analog to be approved in the US

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ACG Packaging Materials' sustainability targets given the SBTi green light

ACG will commit to reducing its scope 1, 2 and 3 GHG emissions to reduce its environmental impact and improve its sustainability credentials

FDA US Agent Services, backed by former regulators and global expertise

If you need a trusted US Agent backed by regulatory experts, NSF can keep your US market entry on track

Almac launches PNPLA3 kit to support liver disease research

New tool enables deeper genetic insight into MASLD and MASH progression

IMed Group scales up growth with new Irish division and top talent

Launch of Irish division IMed EUAR and addition of expert talent drive international expansion and strengthen leadership

3P innovation unveils high-speed DPI filler to support generic respiratory therapies

Patent expiry allows 3P to deliver faster, more cost-effective powder filling technology for inhalable drugs

CI Precision celebrates strong market uptake of SP 60 Series

Pharmaceutical manufacturers report fast ROI and compliance gains two years after launch

Filters to protect ‘your people, process and product’ at Making Pharma 2025

Amazon Filters showcases sustainable filtration solutions for the pharmaceutical industry

FDA US Agent Services, backed by former regulators and global expertise

If you need a trusted US Agent backed by regulatory experts, NSF can keep your US market entry on track

Chemspec Europe 2025 to showcase innovation in fine and speciality chemicals

Leading global trade fair returns to Cologne with a focus on sustainability, regulation, and R&D

How to handle regulatory authority warning letters

What should a company do when they receive a warning letter from the FDA? Find out in this article

Excipients, nitrosamines and risk assessments – creating safer drugs - NOW ON DEMAND

Join us for an in-depth webinar where we’ll explore the complex interplay between excipients, nitrosamines and regulatory compliance – and discover key ways you can...

Executing a successful remediation program: part 1 of 3

This 3-part series looks at what companies need to do to ensure that they have a successful remediation program

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