X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Efficacy Shown On Cystic Fibrosis Patients In 4-Year Study

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Efficacy Shown On Cystic Fibrosis Patients In 4-Year Study

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development

EMA Forms Quality Control Group To Boost Drug Innovation

Content Team by Content Team
24th November 2022
in Drug Development, News

To support innovative approaches for the development, manufacture, and quality control (QC) of medicines, along with new technologies, digitalization, novel materials, and novel devices for patients in the European Union, the European Medicines Agency (EMA) formed the Quality Innovation Expert Group (QIG).

Eight members of the QIG, which was established in September 2022 and reports to the Quality Domain of EMA’s working party organisation, have backgrounds in chemical, biological, and good manufacturing practise (GMP) inspections. The organisation will make sure that the European drug regulatory network maintains its innovative momentum, identifies and fills in regulatory framework gaps, and gives new technology developers more predictability. The group will serve as a forum for discussion and engagement among EU regulators, stakeholders, including academia and industry, and the EU regulatory network, such as the EU Innovation Network. To assist the convergence of worldwide regulatory standards, close coordination with foreign partners will be another goal.

The EMA states that the QIG will do the following to support quality control of medicines:

  • Provide a forum for developers to debate novel approaches to drug development, production, and/or control.
  • Create instructions for cutting-edge production and quality technologies.
  • Participate in training sessions or workshops on pharmaceutical quality for EU evaluators and GMP inspectors.

Identifying novel emerging technologies that are expected to have an impact on regulatory decision-making in the medium to long term is another responsibility, as is developing suitable regulatory reactions in advance as these technologies develop.

The group will contribute to the evaluation of processes used in regulatory submissions that contain these novel technologies, such as scientific recommendations, marketing authorization applications, and pertinent post-authorization lifecycle development.

The regulatory body’s Regulatory Science Strategy to 2025, which outlined important objectives and fundamental suggestions for human pharmaceuticals, will serve as the foundation for the QIG’s activities. These are the strategy’s top five objectives:

  • Promoting the integration of science and technology in the creation of pharmaceuticals
  • Promoting cooperative evidence development and raising the scientific calibre of assessments
  • Partnering with healthcare systems to increase patient-centered access to medications
  • Addressing new risks to health, as well as issues with accessibility and treatment
  • Promoting and making use of regulatory science research and innovation.

Previous Post

Detecting Traces of β-Lactam Antibiotics Using UHPLC-MS-MS

Next Post

Study Bringing Personalised Immunotherapy Therapies Closer

Related Posts

Drug Development

Nasal Spray Shows Its Effect Against New COVID Variants

27th March 2023
FDA Approvals

Mid-Point Regulatory Science Strategy Study Published By EMA

27th March 2023
Drug Development

AADC Inadequacy To Be Handled By A Novel Gene Therapy

24th March 2023
Drug Development

New Drug Explored For Epilepsy Gets $3M Funding In Australia

23rd March 2023
Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials
Clinical Trials

Faster Clinical Trial Nods Planned By The UK To Curb Issues

22nd March 2023
Pharma Drugs Gain From Tardigrade Proteins, Says Research
Drug Development

Pharma Drugs Gain From Tardigrade Proteins, Says Research

22nd March 2023
Next Post

Study Bringing Personalised Immunotherapy Therapies Closer

Latest News

Drug Development

Nasal Spray Shows Its Effect Against New COVID Variants

27th March 2023
FDA Approvals

Mid-Point Regulatory Science Strategy Study Published By EMA

27th March 2023
Drug Development

AADC Inadequacy To Be Handled By A Novel Gene Therapy

24th March 2023
Drug Development

New Drug Explored For Epilepsy Gets $3M Funding In Australia

23rd March 2023
Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials
Clinical Trials

Faster Clinical Trial Nods Planned By The UK To Curb Issues

22nd March 2023
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In