REGULATORY NEWS

REGULATORY NEWS

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  • The US Food and Drug Administration has issued draft guidance, Considerations in Demonstrating Interchangeability With...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  • The US Food and Drug Administration has issued draft guidance, Regulatory Classification of Pharmaceutical Co-Crystals,...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

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

  • 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...

  • 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 ...

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

  • 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 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...

  • 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...

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

  • 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...

  • 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...

  • 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...

  • 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...

  • 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...

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

  • 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,...

  • Guido Rasi Takes the Helm at EMA

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

  • 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 &...

  • 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....

  • 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...

  • EMA Nominates Executive Director

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

  • 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...

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

  • 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...

  • 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...

  • 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 ...

  • 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...

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

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

  • 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...

  • EMA Names PRAC Chair, Vice Chair

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

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

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

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

  • 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...

  • 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...

  • 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...

  • 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...

  • 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...

  • 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...

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

  • 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...

  • 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...

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

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

  • CGPA Forms Biosimilars Board

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

  • 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...

  • 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...

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

  • 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...

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

  • The Energy and House Committee of the US House of Representatives has approved a bill to improve the process for scheduling...

  • The European Medicines Agency (EMA) has published a detailed response to the European Ombudsman’s questions related...

  • The US Food and Drug Administration (FDA) has issued five draft guidances related to drug compounding and repackaging...

  • EMA Reports Progress for SMEs

    The European Medicines Agency (EMA) has issued its annual report on micro-, small- and medium-sized enterprises (SMEs)....

  • US Food and Drug Administration Commissioner Margaret Hamburg will be leaving her post, effective at the end of March...

  • The US Food and Drug Administration (FDA) is requesting a budget of $4.9 billion for fiscal year (FY) 2016, a 9% increased...

  • Following up on his recent announcement in the State of the Union Address, President Barack Obama provided details about...

  • The Chinese Pharmacopeia Commission (ChP) and Waters Corporation, a provider of analytical instrumentation and related...

  • EMA Tackles Antibiotic Resistance

    The European Medicines Agency (EMA), the European Center for Disease Prevention and Control (ECDC), and the European Food...

  • President Barack Obama issued the Administration's fiscal year (FY) 2016 budget, which includes $1.2 billion in federal...

  • The European Medicines Agency (EMA) has launched an electronic repository for periodic safety update reports (PSURs) and...

  • FDA Issues Photosafety Guidance

    The US Food and Drug Administration has released final guidance, Photosafety Evaluation of Pharmaceuticals. The purpose...

  • The US Food and Drug Administration Commissioner Margaret A. Hamburg has appointed Robert Califf, MD., as FDA Deputy Commissioner...

  • The Association of the European Self-Medication Industry (AESGP), the European Federation of Pharmaceutical Industries...

  • The US Food and Drug Administration (FDA) has allowed marketing of the first set of mobile medical apps that allow people...

  • In his State of the Union Address on January 20, 2015, President Barack Obama signaled the launch a new effort, the Precision...

  • The European Medicines Agency has launched the public consultation on how the transparency rules of the European Clinical...

  • The European Medicines Agency (EMA) has published a guide to support the implementation of a new international standard...

  • The European Medicines Agency issued a statement to recommend suspending a number of medicines that had been granted marketing...

  • The United States Pharmacopeial Convention (USP) is announcing plans to establish January 1, 2018 as the new date of applicability...

  • MHRA Appoints CHM Vice Chair

    The UK's Medicines and Healthcare Products Agency (MHRA) has appointed Dr. Angela Thomas has been appointed as vice-chair...

  • Senators Orrin G. Hatch, R-Utah, and Michael Bennet, D-Colo, have re-introduced legislation to create a new drug approval...

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Innovative Medicines Initiative...

  • The European Medicines Agency (EMA) is ready to share its assessments of applications for generic medicines in real time...

  • The US Food and Drug Administration's Center for Drug Evaluation and Research (CDER) has launched a new office within...

  • Drug shortages and supply disruptions are increasingly emerging as a global challenge. As part of the European Medicines...

  • The Biotechnology Industry Organization (BIO) is urging the US Food and Drug Administration to release final guidance...

  • The US Food and Drug Administration (FDA) has published its list of either new or revised draft guidances that the Center...

  • In 2014, the European Medicines Agency (EMA) recommended the highest number of orphan designated medicines for marketing...

  • The US Food and Drug Administration (FDA) announced that it is extending the effective date of certain product tracing...

  • The European Medicines Agency’s (EMA) Management Board has adopted the agency’s work program and budget for 2015 and a...

  • The European Medicines Agency (EMA) has provided an update on the status of its adaptive pathways pilot project. EMA launched...

  • The European Medicines Agency (EMA) issued an interim report on Ebola treatments currently under development and concluded...

  • The US Food and Drug Administration announced the membership of the Pharmacy Compounding Advisory Committee. The committee...

  • The Generic Pharmaceutical Association (GPhA) issued a statement to offer its support for compromised automatic substitution...

  • The US Food and Drug Administration has issued draft guidance describing FDA’s expectations for prescription drug wholesale...

  • Some European Union (EU) member states have decided to suspend the marketing authorizations of medicines that have been...

  • EMA Okays Use of Novartis Vaccine

    The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that there...

  • The European Medicines Agency (EMA) is working with the Italian Medicines Agency (AIFA) and other European Union (EU)...

  • The European Medicines Agency’s (EMA) Management Board held an extraordinary meeting on November 27, 2014 in Rome, Italy...

  • The European Union Civil Service Tribunal has given its judgment in a case involving an appeal by an individual against...

  • Representatives from the generic-drug industry are seeking greater participation in harmonization efforts by gaining membership...

  • The European Medicines Agency (EMA) has made available a new tool to facilitate editing of key data fields by marketing-authorization...

  • The US Food and Drug Administration (FDA) has issued final guidance, Specification of the Unique Facility Identifier...