<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

Contract Service Directory Profiles
Quantum Packaging Technologies Inc.
Search by
Quantum Packaging Technologies Inc.
Company Headquarters
2153 Lodge Road, Flint, MI, 48532, US
Driving Directions Phone: View Phone
View website
Request more information from Quantum Packaging Technologies Inc.
Request more information from Quantum Packaging Technolog

Categories from Quantum Packaging Technologies Inc.

The narrative behind sustainability is changing.
“When there was any presentation about sustainability, I remember people giggling in the room,” said Thermo Fisher’s Geoffroy Malherbe during a presentation at BPI Europe in Hamburg, Germany in May 2025.
In the past 15 years, sustainability has gone from joke, to afterthought, to goal, to a core busi

Sustainability beyond climate change: How the narrative is evolving in biopharma

Pharmaceutical compounding, particularly in 503A and 503B environments, involves complex formulation and regulatory challenges far beyond academic theory. This summary of our extensive article on this topic—written by industry professionals Paul Pluta RPh, PhD, Alan Mancini RPh, Nishant Thakar, RPh, PharmD, and Varanya Chaiyaperm, RPh, PharmD—disti

The 6-Stage Compounding Framework Every Pharmaceutical Manufacturing Professional Should Know

Discover how absorbance-based Process Analytical Technology (PAT) is driving next-generation efficiency in bioprocessing. This webinar explores how integrating PAT into single-use chromatography and Tangential Flow Filtration (TFF) enables real-time monitoring, precise process control, and improved product quality—ultimately reducing variability, p

High Sensitivity PAT in single-use systems for better processing

Samsung Bioepis Co. Ltd. has entered into a license, development and commercialization agreement (DCA) with Harrow for Samsung Bioepis’ ophthalmology portfolio in the U.S. This includes:
BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTISi (ranibizumab)
OPUVIZ (aflibercept-yszy), a biosimilar referencing EYLEAii (aflibercept)
The commerci

Samsung Bioepis Taps Harrow for U.S. Eye Biosimilar Portfolio

Recently, the FDA announced a deadline shift, although the agency did so quietly. On June 23, 2025, FDA updated its CDER Nitrosamine Impurity Acceptable Intake Limits webpage to permit manufacturers and sponsors more time to submit required changes for nitrosamine drug substance‑related impurities (NDSRIs) for approved or currently marketed product

FDA Quietly Eases Nitrosamine Reporting Rules Ahead Of August Deadline

Breadcrumb
Home
About the U.S. Pharmacopeia
USP Volunteers
Our independent Volunteer Experts work together in Expert Committees, sharing their diverse knowledge and perspectives. Each Expert Committee focuses on specific areas that span the work we do to improve health. From the drugs and dietary supplements you take to the foods you eat, USP Volun

2025 - 2030 Expert Committees

Thursday, July 17, 2025
The 7th Annual Pharma Manufacturing and Automation Convention 2025 will take place on October 8th and 9th at Hotel Novotel HICC, Hyderabad, uniting industry pioneers, manufacturing leaders, and future-ready teams to rethink how India’s pharmaceutical sector works, grows, and thrives in building of Smart Plants and Smarter Te

7th Annual Pharma Manufacturing & Automation Convention 2025

FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER)
DRAFT QUESTIONS ______________________________________________________________________________
Page 1 of 1
1. DISCUSSION: Discuss the strength of evidence provided by the two phase 3 studies
00071 and 00072, in particular discuss the impact of the discordant results o

Psychopharmacologic Drugs Advisory Committee (PDAC) Meeting

ARTG ID 501790
ARTG Name
Muscle Multivitamin
Product name
Muscle Multivitamin
ARTG Date
Registration Type
Medicine
Therapeutic good type
Medicine
Sponsor
Noumi Nutritionals Pty Ltd
Ingredients
ascorbic acid
Biotin
calcium pantothenate
chromium picolinate
colecalciferol
copper gluconate
cyanocobalamin
d-alpha-tocopheryl acid succinate
folic acid
iro

Muscle Multivitamin

The OGD has been a bit slow in posting approval actions this month. The total number posted through July 15th are 24 full-approval actions and 2 tentative-approval actions. There were none posted yet for July 16th and 17th, but this may just be a delay in processing the actions through the system. Regardless, with half of the month behind us, the n

Unofficial Mid-July 2025 ANDA Approval Actions

French ophthalmology company Nicox (EPA: ALCOX) has signed an agreement with Japan’s Kowa Company (TYO: 7807).
The deal, worth up to 191.5 million euros ($222 million), grants Kowa exclusive rights to develop and commercialize NCX 470, Nicox’s nitric oxide (NO)-donating bimatoprost eye drop, for the lowering of intraocular pressure (IOP) in patient

Kowa and Nicox sign further deal over glaucoma treatment

On July 15, 2025, Sarepta Therapeutics announced a major round of layoffs tied to restructuring its gene therapy and RNA platforms (1). While painful for those directly affected, the move is part of a broader trend: biopharma is entering a phase of strategic contraction. Companies across the United States and globally are cutting staff, shelving pr

What Sarepta's Layoffs, and Others Across Biopharma, Mean for Industry Professionals

GenesisM, a joint venture between Bain Capital Real Estate and Botanic Properties, has broken ground on its 154,000-square-foot Class A biomanufacturing facility at 45 Crosby Drive in Bedford, Massachusetts. The groundbreaking ceremony was attended by members of the project team, town officials and representatives, and local partners in the biotech

GenesisM Breaks Ground on Biomanufacturing Facility in Bedford, MA

FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER)
QUESTIONS ______________________________________________________________________________
Page 1 of 1
1. DISCUSSION: Discuss whether appropriate dosages of belantamab mafodotin have been
identified for the proposed relapsed /refractory population.
2. VOTE: Is the overa

Oncologic Drugs Advisory Committee (ODAC) Meeting

ARTG Name
Advanced Magnesium Powder+ Peach
Product name
Advanced Magnesium Powder+ Peach
ARTG Date
Registration Type
Medicine
Therapeutic good type
Medicine
Sponsor
JSHealth Vitamins Pty Ltd
Ingredients
magnesium amino acid chelate
magnesium citrate
magnesium glycinate dihydrate
Licence category
LI
Licence status
A
Summary
Download PDF

Advanced Magnesium Powder+ Peach

FDA has approved a prefilled syringe version of GSK’s Shingrix, a recombinant zoster vaccine used to prevent shingles, eliminating the need for reconstitution of separate vials prior to administration (1). The newly approved format aims to ease preparation for healthcare professionals, enhancing efficiency and reducing the risk for handling errors

FDA Approves Shingrix Prefilled Syringe to Simplify Vaccine Administration

Thursday, July 17, 2025
Endeavor BioMedicines has received Orphan Drug Designation for its investigational treatment, taladegib (ENV-101), from both the U.S. Food and Drug Administration (FDA) and the European Commission (EC).
Taladegib is a Hedgehog signalling pathway inhibitor that targets a specific receptor to prevent abnormal myofibroblast acc

Endeavor BioMedicines Secures Orphan Drug Designation for Taladegib in Both U.S. and Europe for Idiopathic Pulmonary Fibrosis

This proposed rule would revoke 23 food standards that are no longer necessary to promote honesty and fair dealing in the interest of consumers. We anticipate benefits from some revoked food standards in the form of producer and consumer surplus generated by increased flexibility. We anticipate cost savings from revoking these food standards in the

Proposal to Revoke 23 Standards of Identity for Foods; Preliminary Regulatory Impact Analysis

6 min read
July 16 is celebrated annually as Artificial Intelligence (AI) Appreciation Day. According to the National Day Archives, AI Appreciation Day was created in May 2021 to acknowledge and celebrate the advancements and positive impact of AI across various industries and aspects of life. In the world of Governance, Risk, and Compliance (GRC),

Top 7 Must-Reads on AI in GRC for AI Appreciation Day

In this video clip from our Industry Outlook interview with him back in March 2025, Tore Bergsteiner, managing partner at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations, discusses how AI is increasingly enhancing diagnostics and pathology by enabling early disease detection through adv

AI Boosts Early Disease Detection and Diagnostic Accuracy

Contract development and manufacturing organizations (CDMOs) play an increasingly vital role in the biopharmaceutical industry—evolving from simple capacity providers to strategic, integrated partners. As biopharma pipelines grow more complex and patient needs become more individualized, CDMOs like Rentschler Biopharma are continuously innovating t

Enhancing CDMO Capabilities to Meet Evolving Client Needs

Real Chemistry has made a flurry of leadership appointments, including hiring JJ Schmuckler from VML to fill a newly created role while also making changes at 21Grams and its communications group.
Schmuckler has joined the healthcare marketing and communications group as group president and chief revenue officer. Real Chemistry said the role will r

Real Chemistry finds its formula, adding a trio of new execs as catalysts for change

Qosina, a global supplier of OEM single-use components for the medical and bioprocess industries, has expanded its partnership with the Bioprocess Solutions business unit of Saint-Gobain, a manufacturer of tubing and polymer solutions. This new distribution agreement allows Qosina to enhance its product portfolio to better support its customers’ ev

Qosina Expands Product Portfolio in Partnership with Saint-Gobain

Waltham, MA - Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, today announced an expansion of their strategic partnership with Sanofi to enable additional U.S. drug product manufacturing. The terms of the deal were not disclosed.
Under the agreement, Thermo Fisher will acquire Sanofi’s steriles manufacturing site in R

Thermo Fisher Scientific To Acquire Sanofi's Sterile Fill/Finish Drug Manufacturing And Packaging Facility In New Jersey

Advertise in the PDA News uPDAte & Buyer’s Guide

Contact

Advertise

Other industries

 Join Us for the 20th Anniversary of the PDA Pharmaceutical Microbiology Conference! 

PDA Pharmaceutical Microbiology Conference 2025 

With the increased expectation to adopt modern microbial methods, more technology users are being tasked with evaluating and developing implementation strategies for advanced methods.
There is a desire to couple regulatory guidelines with industry expertise to develop standardized tools that make implementation a less daunting task and one that is