RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: New Gateway for Parallel Consultations on Marketing Authorizations, HTAs (6 July 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA, EUnetHTA Create Gateway for Parallel Consultations on Marketing Authorizations, HTAs European regulators and health technology assessment (HTA) bodies have advanced their plans to align the data sponsors need to win approval and secure reimbursement. The initiative takes the form of a gateway through which sponsors can request parallel consultations with the Europe...
  • Regulatory NewsRegulatory News

    Australia Proposes New Risk-Based Approach to Medicine Variations

    Australia's Therapeutic Goods Administration (TGA) on Thursday released guidance on a plan to allow companies to make "very low risk" changes to registered medicines after submitting them to TGA and receiving an automated acknowledgement. "These requests are known as 'notifications' but still require an application to the TGA," the regulator explained. "These lowest risk variations do not require evaluation but legally must still be approved by the TGA before imple...
  • Regulatory NewsRegulatory News

    EMA Sets Deadlines for 2016 Type I Variations

    The European Medicines Agency (EMA) on Monday said that marketing authorization holders (MAHs) need to submit any minor changes to drug marketing authorizations, also known as Type IA IN and Type IA variations, for 2016 by 30 November. MAHs are also advised to submit any Type IB variations or groupings of Type IB and Type IA variations in 2016 by 13 December 2016. The deadlines have been set so that EMA can acknowledge the validity of the submissions before the age...
  • Feature ArticlesFeature Articles

    Creating Type IA and Type IB Variation Submissions in Europe

    This article discusses the creation of minor variations within the European Union. Change is constant in the business world. Change, managed correctly enables continuous improvement, a key element of the regulatory compliance systems governing the pharmaceutical industry. Changes need to be assessed in regard to whether they need to be reported to the regulatory agencies, as it may change the information held by the authorities. As part of the marketing application pr...
  • Regulatory NewsRegulatory News

    EMA Touts Big Year for Veterinary Products

    The European Medicines Agency (EMA) recommended 20 new veterinary medicines for approval in 2014, the highest number in the past five years, according to data provided by the regulator. The agency also boasts that it received 29 requests for classification of medicines intended for rare diseases or species with a small population, the most the agency has seen in a single year. Addressing Rare Diseases in Animals In 2009, EMA’s Committee for Medicinal Products for Vete...
  • Regulatory NewsRegulatory News

    Will Your Generic Drug Application Get Rejected by FDA? New Guidance Documents Explain

    The US Food and Drug Administration (FDA) has released two new guidance documents intended to clarify for generic drug makers the criteria by which the agency determines which applications it will "refuse to receive" due to deficiencies in an Abbreviated New Drug Application (ANDA) filing. Background The submission of an ANDA, as with most applications submitted to FDA, involves two stages: the submission of the application to FDA, and FDA agreeing to file the applicati...
  • Regulatory NewsRegulatory News

    What's a Rare Disease for Dogs? FDA Proposes Maintaining Current Levels for Major Species

    Drug regulation is in many ways as much about incentives as it is about requirements. Especially for drugs intended for smaller populations, an incentive—a free review voucher or a speedy review time, for example—may be the difference between a drug existing as a concept or as one available to consumers. Background In the US, patients have long benefited from the Orphan Drug Act , which defines a rare disease as one affecting fewer than 200,000 patients in a given year...
  • RAPS' LatestRAPS' Latest

    Regulators, Industry Discuss Potential Impact of IMDRF

    The International Medical Device Regulators Forum (IMDRF) may be the newest global harmonization body, but you wouldn't know it by looking at its membership or its ambitions. The organization, launched in 2012 as the regulators-only successor to the Global Harmonization Task Force (GHTF), sports an impressive array of members for an organization in its infancy: the US Food and Drug Administration (FDA), Australia's Therapeutic Goods Administration (TGA), Brazil's Nationa...
  • New FDA Staff Policy Manual Defines 'Major Amendments' to Generic Drug Submissions

    The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD) has released a new guideline for its internal review staff on how to handle amendments to generic drug applications. The Manual of Policies and Procedures (MAPP), Reviewer Determination of Major/Minor Amendments to Abbreviated New Drug Applications , is specifically intended for OGD's chemistry review staff. After submitting an original or supplemental Abbreviated New Drug Application (ANDA), ...
  • Australia Implementing Prior Approval for Minor Variations

    Australia's Therapeutic Goods Administration (TGA) has announced planned  amendments to the regulatory requirements for making minor variations to registered prescription drugs. Minor variations include any changes not requiring clinical, nonclinical or quality data to be submitted to regulators, and are typically submitted to TGA under what is known as the Streamlined Submission Process. Under TGA's newly amended regulatory requirements, minor variations will be ...
  • EMA Updates Its Fee Structure Guidance

    The European Medicines Agency (EMA) has released a revised set of rules regarding the fees payable to the agency for the submission of medicinal products and the maintenance of regulatory activities. The rules, released 24 August 2012, include four primary revisions to the existing version, said EMA. The first is a clarification regarding the definition of type II quality variations. Type II variations are defined by EMA as " major variations " that are likely to have...
  • Australia Proposes Changes to How Sponsors Amend Approved Prescription Applications

    Australia's Therapeutic Goods Administration (TGA) announced on 12 June the impending release of proposed changes to how sponsors of registered prescription medications can make "minor variations" to the medicine's entry in the Australian Register of Therapeutic Goods (ARTG). TGA said the changes typically fall under one of four categories: corrections to the entry, a safety-related changes, "self-assessable" quality-related changes or Category 3 quality-level changes. T...