<h2>EU News</h2>
<h3>New Head of EMA</h3>
<p>Emer Cooke is the new Executive Director of the European Medicines Agency. Emer took over as head of the EMA on November 16, 2020. Emer said her priorities for the Agency would be the access and affordability of medicines.</p>
<h3>Clinical Trial Regulation Implementation</h3>
<p>The Clinical Trials (CT) Regulation 536/2014 published on May 28, 2014 has yet to be implemented as it requires a new portal, the Clinical Trials Information System (CTIS), to be operational for new processes to be functional. At its Management Board meeting on June 11, the EMA proposed December 2021 as the go-live date for the CTIS and CT regulation implementation.</p>
<p>Once the CTIS goes live, a three-year transition period to the new system will commence. In the first year of this transition, sponsors of clinical trials will be allowed to submit applications using either the existing EudraCT system or the CTIS. In years two and three, new CTA applications must be done via the CTIS. Trials authorized via EudraCT can continue but must be transferred to the CTIS by end of the three-year transition period.</p>
<h3>Nitrosamine Contamination</h3>
<p>On June 25, 2020, a Committee for Medicinal Products for Human Use (CHMP) Assessment Report recommended extending the requirement to conduct a risk assessment to consider the possibility of the presence of nitrosamine contamination to biological medicinal products. This requirement applies to both new marketing authorization applications and all existing products.</p>
<p>In August 2020, the EMA provided a deadline for the completion of the risk assessments and report of the outcome for biological products and, at the same time, further extended the deadline for products with chemically produced APIs to:</p>
<ul><li>March 31, 2021 for chemical medicines</li><li>July 1, 2021 for biological medicines</li></ul>
<p>In December 2020, the European Pharmacopoeia (Ph. Eur.) Commission adopted a new general chapter on the analysis of N-nitrosamine impurities in active substances (2.5.42, previously listed as 2.4.36).</p>
<h3>Water Quality Guideline</h3>
<p>In July 2020, the EMA issued an update to the &ldquo;Guideline on the quality of water for pharmaceutical use,&rdquo; which becomes effective on February 1, 2021. This revision is the first in 18 years.</p>
<p>The guidance lists the four types of water that can be used for manufacturing drug substances and finished drug products:</p>
<ul><li>Water for injection, which is mainly used for sterile products</li><li>Purified water, which is used for non-sterile products and certain active substances</li><li>Potable water, which can be used for manufacturing active substances and the early stages of cleaning equipment</li><li>Water for the preparation of extracts, which is a new category for herbal products</li></ul>
<p>This new guidance permits the use of potable water for producing the fermentation media and cell culture media in making active substances for biological products, whereas the preceding draft called for using higher-grade purified water for producing such media.</p>
<h2>Brexit</h2>
<p>On December 24, 2020, the EU and UK finally agreed to a trade deal. Annex TBT-2 of this trade deal contains the agreed provisions for medicinal products. The agreement applies to the following medicinal products for human and veterinary use:</p>
<ul><li>Marketed medicinal products for human or veterinary use, including marketed biological and immunological products for human and veterinary use</li><li>Advanced therapy medicinal products</li><li>Active pharmaceutical ingredients for human or veterinary use</li><li>Investigational medicinal products</li></ul>
<p>The agreement includes the following:</p>
<ul><li>Mutual recognition of GMP inspections. Unfortunately, this agreement is not a mutual recognition agreement (MRA) and does not include removing the requirement for re-testing of product made in the UK on importation into the EU, and vice versa. For political reasons this requirement may not be removed for several years, if ever.</li></ul>
<ul><li>Regulatory cooperation</li></ul>
<p>Notable absences from the trade agreement include any mention of herbal medicinal products or medical devices. Also absent is any arrangement for a two-way alert system or pharmacovigilance information sharing.</p>
<p>From January 1, 2021, the MHRA has published a library of new guidance that applied as the transition period came to an end. This guidance covers the following areas:</p>
<ul><li>Clinical trials</li><li>Devices</li><li>Importing and exporting</li><li>IT systems</li><li>Legislation</li><li>Licensing</li><li>Pharmacovigilance</li><li>Pediatrics</li></ul>
<h2>ICH News</h2>
<p>The 2020 ICH biannual meetings, scheduled to be held in Canada in May and Greece in November, were both converted to virtual meetings due to the COVID-19 pandemic and the resulting global travel restrictions. The next ICH meeting is scheduled for June 2021 in South Korea.</p>
<p>In October 2020, the assembly endorsed the concept paper for the revision of Q9, Quality Risk Management. The concept paper for Q9 (R1) lists four areas for improvement with the current application of QRM:</p>
<ul><li>High levels of subjectivity in risk assessments and in QRM outputs</li><li>Product availability risks</li><li>Lack of understanding as to what constitutes formality in QRM work</li><li>Lack of clarity on risk-based decision-making</li></ul>

regulation

European Pharmacopoeia

Emer Cooke

International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Pharma Regulatory

executive director

EudraCT

EU News
New Head of EMA
Emer Cooke is the new Executive Director of the European Medicines Agency. Emer took over as head of the EMA on November 16, 2020. Emer said her priorities for the Agency would be the access and affordability of medicines.
Clinical Trial Regulation Implementation
The Clinical Trials (CT) Regulation 536/2014 published on May

EU, ICH and Brexit Pharma Regulatory Update - July 2020 to January 2021

This research explores improved in vitro models for nasal drug delivery using Reconstructed Nasal Epithelium (RNE) and CT-based 3D printed nasal casts. Traditional models, such as excised animal tissue and idealized airflow casts, have significant limitations—animal tissues are nonviable and variable, while physical casts may allow misleading formu

Use Of Reconstructed Tissue And 3D Printed Ct-based Nasal Casts For The Assessment Of Nasal Delivery

The Scottish Medicines Consortium (SMC), through the National Health Service (NHS) in Scotland, has recommended abaloparatide, which is marketed by London-based Theramex as Eladynos, for treatment of osteoporosis in postmenopausal women who are at very high risk of fracture (1). Theramex and SMC both made the announcement on July 7, 2025, with SMC

Theramex Treatment for Osteoporosis in Postmenopausal Women Accepted by Scottish Medicines Consortium

I like building businesses. In the same way that you build a house, you start with a blueprint and the foundations … then you build around those, move the family in, and keep renovating and expanding as needed. Every stage is important. The foundations of the business must be strong: what is the core idea, what are the company values and vision, an

Balanced Disruption: Leading Change In A Family-Owned Pharma Company

Circio Holding ASA, a biotechnology company developing circular RNA technology for next generation nucleic acid medicine, has expanded its laboratory operations in Stockholm, Sweden.
The move follows Circio’s recent generation of promising circVec circular RNA expression data in the fields of gene and cell therapy. This expansion will enable Circio

Circio Expands Lab Operations in Stockholm

The Australian Research Council (ARC) has awarded a $900,000 Linkage Grant to Smart MCs to support the development of microcarriers for cell-based manufacturing. Working in collaboration with UNSW, the firm’s initiative seeks to build xeno-free microcarriers that can improve scalability, reduce costs, and enhance product quality in biomanufacturing

ARC awards Smart MCs grant to advance microcarrier technology

It’s a rare moment when a CDMO’s market restructuring leads to thoughts about national health policy.
But as I wrote this recent ediorial about Lonza’s decision to focus heavily on biologics, it brought back to my mind an ill-conceived government policy that may have contributed to the company’s restructuring.
No, I’m not referring to tariffs.
It’s

Why CDMOs Are Leaving Small Molecules Behind

Medidex
Getty images. Credit: May Lim
Key takeaways:
New study identifies the pharmaceutical firms with the most drug recalls in the U.S. from 2012-2024.
Aidapak Services leads with 538 total recalls, while King Bio Inc. tops the list for most hazardous Class I recalls with 465 dangerous violations.
The data reveals significant fluctuations in phar

Study Reveals the U.S. Pharmaceutical Firms with the Most FDA Recalls

Target audience
Public health stakeholders involved in GMP activities
The organisations representing stakeholders involved in GMP activities are encouraged to take part in the consultation and to receive all the comments of this consultation from their members, to compile and send the comments via the EU Survey tool.
Why we are consulting
In light

Stakeholders' Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22

ARTG ID 498210
ARTG Name
USA Swisse Ultiboost Sleep
Product name
USA Swisse Ultiboost Sleep
ARTG Date
Registration Type
Medicine
Therapeutic good type
Medicine
Sponsor
Swisse Wellness Pty Ltd
Ingredients
Anemarrhena asphodeloides
Glycyrrhiza glabra
Humulus lupulus
magnesium orotate
Valeriana officinalis
Wolfiporia cocos
Licence category
LIE
Licence

USA Swisse Ultiboost Sleep

Japanese drugmaker Chugai Pharmaceutical (TYO: 4519) has entered into a joint research and license agreement to develop novel therapies for age-related diseases with Singapore-based biotech Gero.
In this collaboration, Chugai - which is majority-owned by Roche (ROG: SIX) - will create novel antibody drug candidates using its proprietary antibody en

Chugai enters into joint research and license accord with Gero

Biosynth, a developer and supplier of critical raw materials and services for life sciences and diagnostics, has opened an expanded GMP bioconjugation facility at its existing Berlin site.
This strategic expansion significantly enhances Biosynth’s specialized manufacturing capabilities in conjugate vaccines and conjugate drugs, activated PEGs, and

Biosynth Opens Expanded GMP Bioconjugation Facility at Berlin Site

Manufacturing or supplying tampons
Guidance
Guidance on how to meet regulatory requirements for the manufacture and supply of tampons in Australia.
Safety review of benzophenone
8 July 2025
Publications
This updated safety review uses the Australian Sunscreen Exposure Model to assess the risk of benzophenone as a degradant in sunscreens.
Safety rev

What's new

The Therapeutic Goods Administration (TGA) has conducted a review of sunscreen ingredients used in Australia and is recommending additional safeguards for 2 ingredients and a sunscreen ingredient by-product (degradant). The review was prompted by regulatory developments overseas, adoption of the Australian sunscreen exposure model and the TGA's sci

TGA to consult on additional controls for some sunscreen ingredients

This webinar, part of a wider series on natural disasters, examines the growing impact of wildfires on respiratory health in the context of climate change. While individuals with existing respiratory conditions are particularly at risk, increasing temperatures and the rise in extreme weather events make this an urgent public health concern for all.

Recording and presentation - EUHPP Live Webinar: Natural disasters and climate change the risks of wildfires for respiratory health (4 July 2025)

Internal controls serve as a fundamental pillar within corporate governance, risk management, and regulatory compliance, ensuring that organizations operate efficiently, ethically, and in line with established laws and regulations. These controls—comprising policies, procedures, and mechanisms—are designed to safeguard assets, ensure the accuracy o

How to Mitigate Limitations of Internal Controls?

Join our webinar to see how MODSIM transforms industrial equipment design by reducing costs and improving collaboration through integrated modeling and simulation.
Industrial equipment manufacturers face significant challenges, particularly in reducing project costs during the bidding phase. Users often must work with pre-defined CAD solutions, whi

MODSIM for Designers in the IE Industry

Ideagen Document Review, formerly known as Ideagen PleaseReview, has partnered with Veeva to offer customers the ability to collaborate on large documents with very high-volume teams—all from within Vault.
Introducing Veeva Vault + Ideagen Document Review
Ideagen Document Review is a real-time document review, co-authoring and redaction software ta

How Ideagen Document Review supports document reviews within Veeva Vault

What would it be like to reduce the audit trail review (ATR) burden in laboratories and manufacturing spaces all while satisfying inspector expectations? With more than 100 external inspections of Eli Lilly and Company’s commercial manufacturing sites conducted in the two years since the company published a novel and enhanced ATR assessment process

A Novel, Enhanced, and Sustainable Approach to Audit Trail Review

Racemization is the process of converting an optically active compound into a racemic (optically inactive) mixture — comprising equal parts of two enantiomers — typically through the application of heat or a chemical reaction. Because many chemical reactions are stereoselective, only one enantiomer often leads to the desired biological effect, whil

Elevating Purity Levels: Racemizing Pharmaceutical Products In Advanced Flow Microreactors

With at-home testing becoming normalized after the pandemic, manufacturers should break down the entire process—from receiving the kit to obtaining the results—and consider how packaging can simplify the process.
Follow this podcast on your favorite streaming platform - links can be found by clicking here.
Learn More

Through the Line: At-home Test Kits

Friday, July 04, 2025
Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., today announced that the European Commission (EC) has granted marketing authorisation in the European Union (EU) for Vevzuo® and Evfraxy® biosimilars of Denosumab.
Vevzuo® is authorised for the prevention of bone complicati

Advancing Bone Health: European Commission Approves Biocon Biologics' Denosumab Biosimilars

Product name
METAGENICS MAGACTIVE MUSCLE POWDER RASPBERRY
ARTG Date
Registration Type
Medicine
Therapeutic good type
Medicine
Sponsor
Metagenics (Aust) Pty Ltd
Ingredients
acetyl levocarnitine hydrochloride
ascorbic acid
calcium hydrogen phosphate dihydrate
chromium nicotinate
glutamine
magnesium glycinate
magnesium glycinate dihydrate
mecobalamin

METAGENICS MAGACTIVE MUSCLE POWDER RASPBERRY

EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.
These medicines are currently the only available treatment for the prevention of RhD immunisation during pregn

Strengthening supply chain of anti-D immunoglobulins

Aging of the global population and the rise of chronic diseases, particularly diabetes, have contributed to an increase in the occurrence of eye diseases, such as glaucoma, keratitis, age-related macular degeneration (AMD), dry eye disorder (DED), and diabetic retinopathy (DR). Pharmaceutical companies have responded with growing investment in the

Advanced Solutions for Sustained Delivery of Ocular Therapies

Next phase builds on 34+ years of serving the needs of US patients and healthcare providers
Columbus, OH /PRNewswire/ - In its ongoing mission to help meet America's growing need for high-quality US-made medicines, Hikma Pharmaceuticals USA today announces it will invest $1 billion by 2030 to further expand its US manufacturing and R&D capabilities

Hikma Pharmaceuticals USA Announces $1B Of New US Investment To Further Expand Its Domestic Manufacturing And Development Of Essential Generic Medicines