REGULATORY NEWS

REGULATORY NEWS

  • The US Food and Drug Administration (FDA) has issued draft guidance, CMC Postapproval Manufacturing Changes for Specified ...

  • The US Senate has voted to pass The FDA Reauthorization Act, which reauthorizes user fees for prescription drugs, generic ...

  • The US Senate voted to pass The FDA Reauthorization Act, which reauthorizes user fees for prescription drugs, generic ...

  • The US Food and Drug Administration (FDA) has released draft goals and procedures for a potential user fee program for nonprescription ...

  • The US Food and Drug Administration (FDA) has announced its intent to establish a pilot-project program under the Drug Supply ...

  • Following the passage in the US House of Representatives of a bill that would reauthorize user fees for prescription drugs, ...

  • The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb highlighted the staffing priorities at the agency ...

  • The US Food and Drug Administration (FDA) has provided details of the implementation of the 21st Century Cures Act , which ...

  • The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) are stepping up ...

  • The US Food and Drug Administration (FDA) has issued draft guidance, Product Identifier Requirements Under the Drug Supply ...

  • The US Food and Drug Administration (FDA) has unveiled a strategic plan to eliminate the agency’s existing orphan designation ...

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the pharmaceutical industry ...

  • Among the decisions made at its most recent meeting held May 27 to June 1, 2017 in Montreal, Canada, the International Council ...

  • The US Food and Drug Administration (FDA) will hold a public meeting on July 18, 2017 to discuss ways to improve the generic-drug ...

  • The US Food and Drug  Commissioner Scott Gottlieb issued a statement to further amplify on the agency's plan to address ...

  • The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the US Food and ...

  • In a landmark decision, the US Supreme Court ruled in favor of biosimilar developers regarding notification requirements ...

  • The US Senate Committee on Health, Education, Labor and Pensions (HELP) will hold a hearing next week, on Tuesday June 13, ...

  • In a vote of 54-0, the Energy and Commerce Committee of the US House of Representatives voted to advance the bill, The ...

  • The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies ...

  • The new Commissioner of the US Food and Drug Administration (FDA), Dr. Scott Gottlieb,   testified before the Subcommittee ...

  • President Donald Trump's FY 2018 budget proposal for the FDA, released this week, sets up a battle with Congress as the ...

  • Reflecting the changing nature of drug development to precision medicines, the US Food and Drug Administration (FDA) has ...

  • A report by the European Medicines Agency (EMA) shows that in 2016, European inspectors issued non-GMP compliance statements ...

  • Scott Gottlieb, MD, the new Commissioner of the US Food and Drug Administration (FDA), addressed his staff for the first ...

  • Tom Price, the US Secretary of Health and Human Services (HHS), advanced the Administration's budget blueprint in calling ...

  • For the first time in more than 20 years, Canada is proposing changes to its drug-pricing regulations, including a proposal ...

  • The US Senate has confirmed the nomination of Scott Gottlieb, MD, as the next Commissioner of the US Food and Drug Administration ...

  • The European Medicines Agency (EMA) has notified marketing authorization holders (MAHs) to prepare for drug authorization ...

  • At a recent meeting held between European Medicines Agency (EMA) officials and the heads of the National Competent Authorities ...

  • The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) released a new report on the trends from its inspection ...

  • The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have released a report on the results ...

  • The Pharmaceutical Research and Manufacturers of America (PhRMA) provided comments to a recent report by the US Food and ...

  • Leaders of the US House of Representatives and Senate health committees have released a discussion draft of bipartisan legislation,  ...

  • The European Parliament has passed a resolution in early April 2017 that outlines the provisions for the UK’s exit from ...

  • Industry stakeholders, including Pfizer and QuintilesIMS, have issued comments in response to the US Food and Drug Administrations ...

  • In a hearing of the US Senate Committee on Health, Education, Labor and Pensions held in early April 2017, representatives ...

  • Scott Gottlieb, MD, the nominee for US Food and Drug Administration (FDA) Commissioner, testified before Congress in a hearing ...

  • The US Food and Drug Administrations (FDA) Center for Drug Evaluation and Research (CDER) has outlined priority goals in ...

  • The US Food and Drug Administration and the European Commission (EC) have adopted an agreement whereby US and European Union ...

  • The Generic Pharmaceutical Association, a trade group representing generic pharmaceutical and biosimilar companies, has ...

  • The European Directorate for the Quality of Medicines and Healthcare (EDQM), the standards-setting organization for pharmacopeial ...

  • Prime Minister Theresa May in a speech this week provided a 12-point plan of broad objectives of the UK plans to exit the ...

  • The US Food and Drug Administration has issued draft guidance, Considerations in Demonstrating Interchangeability With ...

  • FDA Issues Biosimilars Guidance

    The US Food and Drug Administration (FDA) has issued final guidance, Clinical Pharmacology: Data to Support a Demonstration ...

  • The Center for Drug Evaluation and Research (CDER) in the US Food and Drug Administration (FDA) has announced the formation ...

  • The US Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research and Small Business and Industry ...

  • The US Food and Drug Administration (FDA) and the generic drug manufacturing industry —including representatives of generic ...

  • The US Food and Drug Administration has issued draft guidance, Regulatory Classification of Pharmaceutical Co-Crystals, ...

  • The European Medicines Agency (EMA) has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), ...

  • The European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) is organizing a workshop on November 15 and ...

  • The European Medicines Agency (EMA) has released n ew good manufacturing practice (GMP) guidance to ensure the integrity ...

  • The UK government announced that the Office for Life Sciences will continue to be a joint unit across the Department of ...

  • EMA Announces Reorganization

    The European Medicines Agency (EMA) has announced some organizational adjustments and important strategic amendments of ...

  • The European Medicines Agency (EMA) has published a draft guideline to support and guide the use of innovative modelling ...

  • The US Food and Drug Administration (FDA)has approved safety labeling changes for a class of antibiotics, called fluoroquinolones, ...

  • The US Food and Drug Administration (FDA) has announced the rates for abbreviated new drug applications (ANDAs), prior approval ...

  • The European Medicines Agency (EMA), in cooperation with the European Commission and the member states of the European Union ...

  • The European Medicines Agency (EMA) has recommended suspending a number of nationally approved medicines for which bioequivalence ...

  • The European Medicines Agency (EMA) has assured that its procedures and work stream are not affected by the United Kingdom’s ...

  • The US Food and Drug Administration (FDA) has issued the Quality Metrics Technical Conformance Guide, a technical specification ...

  • Industry group representing innovator drug companies and generic drug companies have taken opposite positions regarding ...

  • The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have set up a new cluster on patient engagement. ...

  • The European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) has appointed Dr. David ...

  • President Barack Obama signed into law legislation that reformed the Toxic Control Substances Control Act (TSCA). TSCA, ...

  • The US Food and Drug Administration (FDA) has issued draft guidance, Quality Attribute Considerations for Chewable Tablets, ...

  • As of June 13, 2016, all periodic safety update reports (PSURs) for human medicines authorized in the European Union (EU) ...

  • The US Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, has taken ...

  • The US Food and Drug Administration (FDA) has re-iterated its position to include suffixes in its naming conventions for ...

  • The European Medicines Agency (EMA) has released the outcome of the assessment of the first batch of applications received ...

  • The European Medicines Agency (EMA) has published a report from a multi-stakeholder expert meeting held on May 27, 2016 ...

  • EMA Issues Annual Report

    The European Medicines Agency (EMA) has published its 2015 annual report to highlight its key activities and goals. ...

  • The White House Office of Science and Technology Policy (OSTP), in collaboration with federal agencies and private-sector ...

  • To improve protection for workers from cancer-causing chemicals, the European Commission has proposed changes to the Carcinogens ...

  • In an article published in The New England Journal of Medicine , two representatives of the European Medicines Agency (EMA), ...

  • The US Food and Drug Administration (FDA) will hold a public meeting on June 10, 2016 in Silver Spring, Maryland, to ...

  • The US Food and Drug Administration has issued draft guideance, Chronic Hepatitis C Virus Infection: Developing Direct-Acting ...

  • The US Food and Drug Administration (FDA) has issued draft guidance, Special Protocol Assessment, to specify t the procedures ...

  • The US Food and Drug Administration (FDA) has issued draft guidance, Assay Development and Validation for Immunogenicity ...

  • The European Medicines Agency (EMA) has published new guidance on the use of patient-reported outcome (PRO) measures in ...

  • FDA Issues Draft CMC Guidance

    The US Food and Drug Administration (FDA) has issued draft guidance, Comparability Protocols for Human Drugs and Biologics: ...

  • The European Medicines Agency (EMA) and the European network for Health Technology Assessment (EUnetHTA) have published ...

  • A new industry body, the British Biosimilars Association (BBA), has been formally launched with the sole focus of increasing ...

  • The US Food and Drug Administration has issued draft guidance, Data Integrity and Compliance With CGMP, to clarify the ...

  • The US Food and Drug Administration has issued final guidance, Safety Considerations for Product Design to Minimize Medication ...

  • The European Medicines Agency (EMA) has published a preliminary version of its draft reflection paper that outlines a framework ...

  • The US Food and Drug Administration has issued draft guidance, Labeling for Biosimilar Products, to assist applicants ...

  • The US Food and Drug Administration (FDA) has issued final guidance, Contents of a Complete Submission for the Evaluation ...

  • The European Pharmacopoeia (Ph. Eur.) Commission elected Dr Tobias Gosdschan as its chair for a term from June 2016 to June ...

  • The European Pharmacopoeia (Ph. Eur.) Commission adopted a revision of its monograph for Water for Injections (0169). Up ...

  • The European Medicines Agency (EMA) has published a report on its pilot on parallel scientific advice with health-technology-assessment ...

  • In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the US Food ...

  • The US Food and Drug Administration (FDA) has issued a draft guidance intended to support industry in its development of ...

  • India's Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) have issued proposed ...

  • The Swiss Agency for Therapeutic Products (Swissmedic), the national drug regulatory agency for Switzerland, reports that ...

  • The European Medicines Agency (EMA) has launched its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines ...

  • EMA Issues Risk Management Module

    The European Medicines Agency (EMA) has published a revision of Module V of the good pharmacovigilance practices (GVP) ...

  • The US Food and Drug Administration (FDA) has issued final guidance, Completeness Assessments for Type II API DMFs Under ...

  • In response to concerns about substandard and counterfeit medicines and a growing demand for quality-assured medicines in ...

  • The MEDICRIME Convention, aninternational treaty against counterfeit medical products and similar crimes involving threats ...

  • The European Medicines Agency (EMA) and the European Commission (EC) have prepared an implementation plan for centrally ...

  • The European Medicines Agency (EMA) has established a task force of European experts with specialized knowledge in vaccines, ...

  • As part of the federal budget process, the US Food and Drug Administration is requesting a total budget of $5.1 billion ...

  • The European Medicines Agency (EMA) has released a revised guideline on medicines for the treatment of Alzheimer’s disease ...

  • The US Food and Drug Administration (FDA) published its guidance agenda for calendar year 2016 and identified the new and ...

  • BIO Changes Its Name

    The Biotechnology Industry Organization (BIO) has changed its name to the Biotechnology Innovation Organization (BIO). ...

  • The US Food and Drug Administration (FDA) has issued draft guidance, Advancement of Emerging Technology Applications to ...

  • The European Medicines Agency (EMA) Management Board and the Heads of Medicines Agencies (HMA) have adopted a common strategy ...

  • The Associated Chambers of Commerce & Industry of India (ASSOCHAM) and the research firm, RNCOS, have issued a report highlighting ...

  • The European Medicines Agency (EMA) Executive Director Guido Rasi outlined his vision for his five-year mandate at the helm ...

  • President Barack Obama has signed into law, the "Improving Regulatory Transparency for New Medical Therapies Act," which ...

  • The European Medicines Agency (EMA) has published a good practice guide on medication errors to improve the reporting, evaluation, ...

  • Guido Rasi Takes the Helm at EMA

    Professor Guido Rasi has taken office as executive director of the European Medicines Agency (EMA). Professor Rasi is ...

  • EMA Issues Draft Guidance on PAES

    The European Medicines Agency (EMA) has released a draft scientific guideline that outlines how post-authorization efficacy ...

  • The European Medicines Verification Organization (EMVO) and the European Directorate for the Quality of Medicines & HealthCare ...

  • The NSF Health Sciences Certification, LLC (NSF), which provides testing, auditing, certification, and training for the ...

  • The International Council for Harmonization (ICH), formerly the International Conference on Harmonization, held the inaugural ...

  • The United States Pharmacopeial Convention (USP) has submitted its comments on the US Food and Drug Administration’s (FDA) ...

  • The US Food and Drug Administration (FDA) has issued revised draft guidance, Liposome Drug Products Chemistry, Manufacturing, ...

  • The European Medicines Agency (EMA) has launched a public consultation on the key principles of its new PRIME scheme. PRIME ...

  • The European Medicines Agency (EMA) has launched an initiative on patient registries aimed at making better use of existing ...

  • The Medicines and Healthcare products Regulatory Agency (MHRA), the UK's regulatory authority, has signed a memorandum of ...

  • EMA Nominates Executive Director

    The European Medicines Agency’s (EMA’s) management board has nominated Professor Guido Rasi as the executive director of ...

  • The European Medicines Agency (EMA) has released a draft guideline for public consultation on the use of pharmacokinetics ...

  • The European Medicines Agency’s (EMA) Management Board will meet on October 1, 2015 for an extraordinary session to nominate ...

  • President Barack Obama has announced his intent to nominate Dr. Rob Califf as the next Commissioner of the US Food and Drug ...

  • Stakeholders in the European healthcare and pharmaceutical industry have published the Riga Roadmap, an action plan to make ...

  • The US Food and Drug Administration (FDA) has issued final guidance, Q3D Elemental Impurities in line with the guideline ...

  • The US Food and Drug Administration (FDA) has issued draft guidance, Formal Dispute Resolution: Appeals Above the Division ...

  • EMA Plans Orphan Drug Workshop

    The European Medicines Agency (EMA) is organizing a workshop on December 7, 2015 to discuss the approach that should be ...

  • The European Medicines Agency (EMA) began its full medical literature monitoring service on September 1, 2015. A total of ...

  • The US Food and Drug Administration (FDA) has issued draft guidance, Nonproprietary Naming of Biological Products; Draft ...

  • The European Medicines Agency has released an addendum to the International Conference on Harmonization of Technical Requirements ...

  • The European Commission (EC) has issued his draft regulations to detail the rules for the implementation of obligatory safety ...

  • The US Food and Drug Administration (FDA) has issued draft guidance, Botanical Drug Development, to describe the Center ...

  • The US Food and Drug Administration (FDA) has issued draft guidance, Rare Diseases:Common Issues in Drug Developmen t ...

  • The members of the GMP Committee of the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) ...

  • EMA Endorses EU IT Roadmap

    The European Medicines Agency (EMA) Management Board has endorsed the European Union (EU) Telematics Strategy and Implementation ...

  • The US Food and Drug Administration (FDA) has issued draft guidance, Dissolution Testing and Specification Criteria for ...

  • FDA Sets GDUFA Fees

    The US Food and Drug Administration (FDA) has announced the rates for abbreviated new drug applications (ANDAs), prior approval ...

  • The US Food and Drug Administration (FDA) has issued draft guidance, Request for Quality Metrics, to explain how the Center ...

  • The US Food and Drug Administration (FDA) has issued final guidance, Analytical Procedures and Methods Validation for Drugs ...

  • The European Medicines Agency (EMA) has revised its guidelines on the implementation of accelerated assessment and conditional ...

  • The European Medicines Agency (EMA) is launching a 12-month pilot to encourage companies to seek scientific advice for post-authorization ...

  • EMA Names PRAC Chair, Vice Chair

    At its July 2015 meeting, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) voted to prolong ...

  • The European Medicines Agency (EMA) is launching a public register of parallel distribution notices to provide a more transparent ...

  • The European Medicines Agency (EMA) has released for consultation product-specific guidance on bioequivalence studies for ...

  • The International Conference on Harmonization (ICH) reports that its Addendum, "Assessment and Control of DNA Reactive (Mutagenic) ...

  • The US Food and Drug Administration (FDA) is amending its regulations to implement certain drug shortages provisions of ...

  • The European Medicines Agency (EMA) has published the outcome of a workshop that explored how to ensure the availability ...

  • The European Medicines Agency (EMA) has started a review of human papillomavirus (HPV) vaccines to further clarify aspects ...

  • The Health and Food Safety Directorate-General of the European Commission has launched a call for expressions of interest ...

  • Senior leaders from the US Food and Drug Administration (FDA), the European Commission,and the European Medicines Agency ...

  • The European Medicines Agency (EMA) has announced a new logo system in the European Union (EU) to identify legally operating ...

  • he European Medicines Agency (EMA) has started to publish the outcomes of single assessments of periodic safety update reports ...

  • The US Food and Drug Administration (FDA) has issued final guidance, Allowable Excess Volume and Labeled Vial Fill Size ...

  • The US Food and Drug Administration (FDA) has issued final guidance, DSCSA Implementation: Product Tracing Requirements ...

  • The European Medicines Verification Organization (EMVO) is a Luxembourgish non-profit organization representing stakeholder ...

  • BIO Plans Name Change

    The Biotechnology Industry Organization (BIO) announced that it will change the name of the organization to the Biotechnology ...

  • The National Institutes of Health (NIH) has submitted interim corrective action plans to the US Food and Drug Administration ...

  • The International Conference on Harmonization (ICH) reports that the ICH Q7 Questions and Answers on Good Manufacturing ...

  • The US Food and Drug Administration (FDA) has issued final guidance, Naming of Drug Products Containing Salt Drug Substances, ...

  • The US Food and Drug Administration (FDA) has issued final guidance, Size, Shape, and Other Physical Attributes of Generic ...

  • The US Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, has taken ...

  • The European Medicines Agency (EMA) has launched an initiative that offers free-of-charge early pediatric interaction meetings ...

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) issued support for data protection reform ...

  • The European Medicines Agency (EMA) Management Board gave its green light for the central repository for periodic safety ...

  • The European Medicines Agency (EMA) will hold a webinar on Wednesday June 24, 2015, to update stakeholders on the implementation ...

  • The National Institutes of Health (NIH) has suspended production of sterile materials at its operations at the Pharmaceutical ...

  • The US Food and Drug Administration (FDA) has issued final guidance, ANDA Submissions–Refuse-to-Receive Standards: Guidance ...

  • The US Food and Drug Administration (FDA) has issued final guidance, M7 Assessment and Control of DNA Reactive (Mutagenic) ...

  • The US Food and Drug Administration (FDA) has issued draft guidance to address the lack of clarity with respect to what ...

  • The European Medicines Agency (EMA) has issued an update of the European Union (EU) recommendations for the influenza virus ...

  • The European Medicines Agency (EMA) has confirmed its recommendation to suspend a number of medicines for which authorization ...

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the China Pharmaceutical Industry Association ...

  • The European Medicines Agency (EMA) has published the list of active substances and a reference to the journals that will ...

  • As part of its overall efforts to address compounded drugs, the US Food and Drug Administration (FDA) today released a draft ...

  • A coalition of 11 companies involved in the development and manufacturing of biopharmaceuticals and “biosimilar” medicines ...

  • The US Food and Drug Administration (FDA) has issued three final guidances on biosimilars. The final guidances are: Biosimilars: ...

  • The US Food and Drug Administration (FDA) has issued draft guidance, Waiver of In Vivo Bioavailability and Bioequivalence ...

  • The US Food and Drug Administration (FDA) has issued final guidance, Pr oviding Regulatory Submissions in Electronic Format—Certain ...

  • EMA Issues Progress Report

    The European Medicines Agency (EMA) issued an annual report to highlight the agency's progress in 2014 in advancing key ...

  • The US Food and Drug Administration (FDA) has issued a proposed rule requesting additional scientific data to support the ...

  • Three articles co-authored by researchers at the US Pharmacopeial Convention (USP) were published in a supplement to the ...

  • GPhA Launches Biosimilars Council

    The Generic Pharmaceutical Association (GPhA) has launched the Biosimilars Council, a division of GPhA. "The Biosimilars ...

  • Kenneth C. Frazier, chairman and chief executive officer (CEO) of Merck & Co., Inc., has been elected chairman of the board ...

  • Health Canada, the national pharmaceutical regulatory agency of Canada, has launched the Drug and Health Product Inspections ...

  • The board of the European Biopharmaceutical Enterprises, a specialized group with the European Federation of Pharmaceutical ...

  • The National Coordinating Council for Medication Error Reporting and Prevention has created an Adverse Drug Event (ADE) ...

  • Former US Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg has been appointed as the next foreign secretary ...

  • FDA Issues Draft REMS Guidance

    The US Food and Drug Administration (FDA) has issued draft guidance, Risk Evaluation and Mitigation Strategies: Modifications ...

  • The Generic Pharmaceutical Association (GPhA) issued its support of public meeting held by the US Food and Drug Administration ...

  • The European Generic and Biosimilar medicines Association (EGA) supported a new French national action plan to promote generic ...

  • The European Medicines Agency's Enpr-EMA, a network of research networks, investigators and centers with expertise in performing ...

  • The International Pharmaceutical Excipients Council (IPEC)-Americas has issued a position paper, Implementation of the NSF/IPEC/ANSI ...

  • CGPA Forms Biosimilars Board

    The Canadian Generic Pharmaceutical Association (CGPA) has established a new CGPA Biosimilars Board and elected Michel Robidoux, ...

  • CGPA Names Chair, Vice Chair

    The Canadian Generic Pharmaceutical Association (CGPA) has elected Jeff Watson, president of global generics at Apotex, ...

  • The United States Pharmacopeial Convention (USP) has announced the establishment of an implementation date of January 1, ...

  • As previously announced, Dr. Stephen Ostroff, MD,became the US Food and Drug Administration's Acting Commissioner of Food ...

  • The US Food and Drug Administration (FDA) has issued draft guidance to provide recommendations to applicants of new drug ...

  • The US Food and Drug Administration (FDA) issued a final guidance to assist industry in developing opioid drug products ...

  • EMA Lowers Fees Slightly

    Fees payable to the European Medicines Agency (EMA) by applicants and marketing-authorization holders decreased by 0.1%, ...

  • USP Names GM Of USP-China

    The United States Pharmacopeial Convention announced that Bingbing Feng will become Vice President and General Manager of ...

  • The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have released the "EU Medicines Agencies Network ...

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Generic medicines Agency (EGA), ...

  • The European Generic medicines Association (EGA), an industry association representing generic drug and biosimilar industries, ...

  • Richard Bergström, EFPIA Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), ...

  • The European Directorate for the Quality of Medicines and Health Care (EDQM), which is responsible for the European Pharmacopoeia ...

  • The European Directorate for the Quality of Medicines and HealthCare (EDQM), which is responsible for the European Pharmacopoeia ...

  • Health Canada, the national regulatory authority of Canada, has advised drug establishment license holders that it will ...

  • FDA Launches Drug Shortages App

    The US Food and Drug Administration (FDA) has launched the agency’s first mobile application (app) specifically designed ...

  • Following the recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...

  • EMA Plans Modest Fee Increase

    The European Medicines Agency (EMA) reminds applicants and marketing-authorization holders that adjusted fees will be coming ...

  • The European Medicines Agency (EMA) is establishing a task force for the implementation of international standards for the ...