TwitterLinkedin

Contact Us

  • Biopharma Excellence
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Current Opportunities
  • Training
Top Bar
Search
PharmaLex Logo
MENUMENU
  • PharmaLex Logo
  • PharmaLex Logo
  • About UsAbout Us
    • About Us
    • Management Team
    • Corporate Social Responsibility
    • What Our Clients Say About Us
  • Our Services
    • Discovery / Non-clinical
          • Go to Discovery / Non-clinical section >>

          • Strategy and Consulting

            • Integrated Product Development
            • Market Access
            • Scientific Advice
            • Statistics and Data Sciences
            • Toxicology Services
    • Clinical Development
          • Go to Clinical Development section >>

          • Strategy and Consulting

            • Clinical Program Development
            • Scientific Advice
            • Statistics and Data Sciences
          • Regulatory Affairs

            • Clinical Trial Applications
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Regulatory Operations
          • Pharmacovigilance

            • Clinical Trial Safety Support
            • Pharmacovigilance Consulting
          • Quality

            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
            • Tech Transfer / Scale-up
    • Authorization / Approval
          • Go to Authorization / Approval section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Regulatory Operations
            • Scientific, Regulatory and Technical Writing
            • Statistics and Data Sciences
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • Pharmacovigilance Consulting
          • Quality

            • Commercialization Readiness
            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • PAI Readiness
    • Post-approval / Maintenance
          • Go to Post-approval / Maintenance section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Mergers and Acquisitions (M&A) Transfers
            • Regulatory Operations
            • Toxicology Services
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • ICSR (Individual Safety Case Report) Management
            • Literature Monitoring & Screening
            • Pharmacovigilance Quality & Compliance
            • Signal Management
          • Quality

            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
          • Medical Affairs

            • Healthcare Compliance and Medical Approval
    • Program Management
          • Go to Program Management section >>

          • Program Management

            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Integrated Product Development
            • Mergers and Acquisitions (M&A) Transfers
    • Featured Expertise
          • Industry Expertise

            • Biopharmaceuticals
            • MedTech Services
          • Service Expertise

            • ATMP / Cell and Gene Therapy
            • COVID-19 Support
            • GxP Services
            • Market Access
            • Pharmacovigilance Consulting
            • Post-Brexit Regulatory Support
            • Statistics and Data Sciences
            • SMARTPHLEX - technology-enabled services
  • Global ReachGlobal Reach
  • Contact usContact us
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Career Opportunities
  • Training
Home > News & Events > Industry News Articles > Nitrosamines – NEW DEADLINE for Marketing Authorization Holders

Nitrosamines – NEW DEADLINE for Marketing Authorization Holders

Following our last article in April 2020 regarding the impending deadline for nitrosamines, the EMA first extended the deadline to complete the risk evaluation for commercial drugs to 01 October 2020 due to the COVID-19 pandemic. The deadline for the risk evaluation has since been extended to 31 March 2021. An updated Q&A was published in August 2020. In addition, in July 2020 the scope was widened to include biologic active substances, for these the risk evaluation must be completed by 01 July 2021. Confirmatory testing and submission of manufacturing changes via variation applications should be completed by 26 September 2022 for chemical and 01 July 2023 for biological medicines. Information regarding the requirements for Marketing Authorization Holders (MAH) remains the same. The EMA publication from June 2020, instructing MAH to take precautionary measures to mitigate the risk of nitrosamine formation or presences during manufacture of all medicines containing chemically synthesized active substances can be found here>>

The publication also serves as a reminder of the responsibilities of the MAH as laid down in Directive 2001/83/EC. While the MAH can delegate activities such as API manufacturing, they cannot delegate responsibility for ensuring the quality, safety and efficacy of the finished product for the patient.

Additionally, the US FDA recently released a guidance for industry in September 2020. The FDA expects that the risk assessment for all currently approved or marketed drug products (including their respective APIs) conclude within 6 months of guidance publication (i.e. by end of February 2021), and confirmatory testing and submission of required changes conclude within 3 years (i.e. by September 2023). Pending applications’ risk assessments and confirmatory testing should be performed expeditiously.

The MAH together with API and finished product manufacturers should perform a risk evaluation using Quality Risk Management Principles that are set out in ICH Q9 of their medicinal products containing chemically synthesized API. The risk assessment should consist of the identification of hazards and the analysis and evaluation of risks associated with the arrangements for preventing nitrosamine formation as well as contamination or cross contamination. The following products are under scope:

  • Approved products (reference listed drugs, generics and OTCs)
  • On-going procedures
  • Investigational Medicinal Products (IMPs)

Key questions to consider during the risk assessment are:

  1. Is there a risk of nitrosamines forming in the API synthetic process taking into consideration the combination of reagents, solvents, catalysts and starting materials used, intermediates formed, impurities and degradants?
  2. Is there a potential risk of nitrosamine contamination (e.g. from recovered materials such as solvents, reagents and catalysts, equipment, degradation, starting materials or intermediates)?
  3. Is there any potential of nitrosamine formation during the manufacture of the finished product and/or during storage throughout its shelf life?

Should the risk evaluation lead to the identification of nitrosamines confirmatory testing should be performed using appropriately validated and sensitive testing methods. Following that, updates to the MAH may be required.

PharmaLex can support companies in making sure that they understand the regulatory requirements in relation to nitrosamines, that their risk assessment is valid, that they are carrying out appropriate testing, and that they are interpreting the information correctly. Contact us at contact@pharmalex.com

Related posts
NLS DAYS 2022
NLS DAYS 2022
September 28 - May 29th, 2022
Addressing Limitations of Sterility Testing
Addressing Limitations of Sterility Testing
9th May 2022
Are virtual audits sustainable post-pandemic?
Are virtual audits sustainable post-pandemic?
6th May 2022
Orphan Drug Designation: Securing the Significant Benefits
Orphan Drug Designation: Securing the Significant Benefits
28th March 2022
Virtual Audits: To be, or not to be, that is the question
Virtual Audits: To be, or not to be, that is the question
26th January 2022
Quality Risk Management ICH Q9 – Revision published for public comments
Quality Risk Management ICH Q9 – Revision published for public comments
5th January 2022
Search
Upcoming Events

September 28 - May 29th, 2022

NLS DAYS 2022

Visit us at booth X51

Categories
  • All News
  • Webinars
  • Events
Archive
Biopharma Excellence Website Image

PharmaLex Brings You Biopharma Excellence

Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence – all under the PharmaLex brand. This global team of scientific, regulatory and commercial professionals provide strategic product development and proactive regulatory services to developers of biopharmaceuticals, cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.

Visit Website
USEFUL LINKS
  • Home
  • Contact us
  • Imprint
  • Data Protection
  • Terms and Conditions
RECENT TWEETS
PharmaLexGLOBALPharmaLex@PharmaLexGLOBAL·
17 May

At PharmaLex, one of our core values is expanding our global community. In March, we welcomed Japan, East Asia, and Southeast Asia into our global pharmaceutical #productdevelopment as a result of a merger agreement with Ascent Development Services.
https://lnkd.in/eGFf_AKv

COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY
  • I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.

    Lorraine Henry
    Compliance Lead, Qualified Person, Amneal Ireland Limited
PharmaLex
©2022 PharmaLex GmbH. All rights reserved.

ISO9001:2015 LogoEnergie Audit LogoSGS Logo

Suspicious Emails

We are aware of a number of suspicious emails about recruitment in circulation purporting to be from PharmaLex. Emails sent by PharmaLex will originate from @pharmalex.com. Should you receive an email and are unsure as to its validity, please report it to contact@pharmalex.com.

Many thanks for your understanding.

The PharmaLex Team

    Please DO NOT send us event/conference information.
    We will not respond and these will be deleted immediately.





    Select your state:

    .
    If you do not wish to receive any communication from us, you may unsubscribe at any time.

    #AskTheExpert #TogetherBEYONDCOVID19





      Select your state:

      .
      You can unsubscribe at any time at data.protection@pharmalex.com

      If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

      #TogetherBEYONDCOVID19

      We closely monitor developments and updates surrounding the current outbreak of Coronavirus Disease 2019 (COVID-19) from official sources including the World Health Organisation and are following the guidance and direction of the governments and the local authorities. We are taking this situation very seriously and our number one priority is the safety and business continuity for our customers and colleagues. As ever, we will do everything we can to ensure that services are delivered within the required time and the trusted quality PharmaLex is known for