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  • Regulatory NewsRegulatory News

    MHRA Consults on Analytical Quality by Design Principles

    The UK’s Medicines and Health care products Regulatory Agency (MHRA) on Tuesday opened a three-month public consultation on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeial standards.   “Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management,” MHRA writes.   Th...
  • Regulatory NewsRegulatory News

    Health Canada Opens Generic Drug Guidances for Consultation

    Health Canada last week released two draft guidances for public consultation as part of the agency’s effort to clarify the criteria for its abbreviated new drug submission (ANDS) pathway for generic drugs.   Specifically, the draft guidances detail how the agency intends to implement a recently proposed regulatory amendment aimed at boosting access to generic drugs and making labeling more consistent and transparent.   “The draft guidance documents have been releas...
  • Regulatory NewsRegulatory News

    Australia Proposes to Reclassify Spinal Implants in Line With EU MDR

    Australia’s Therapeutic Goods Administration (TGA) opened a consultation on Monday to obtain feedback on its proposal to reclassify all spinal implantable medical devices to a higher risk level. The consultation describes the reasoning behind changing the current Class IIb classification of medium-high risk on spinal implants to Class III under a new classification rule. It comes as part of an effort to align Australia’s regulatory requirements with the new framework of...
  • Regulatory NewsRegulatory News

    EU Begins Transition to Electronic Product Information for Medicines

    The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) on Thursday launched a six-month public consultation on the draft key principles that will form the basis for creating electronic product information (ePI) for medicines in the EU. Derived from conversations with EMA, EC, HMA and various stakeholders, the draft key principles explain how ePI, which includes the package leaflet for patients and the summary of product...
  • Regulatory NewsRegulatory News

    Pharma Inspection Co-operation Scheme Criticizes Plan to Lower GMP Requirements for ATMPs

    The regulatory group known as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) said in a letter released this week that it is “unanimously concerned” about the public health and safety impact of a new European Commission guideline that would lower good manufacturing practice (GMP) requirements for advanced therapy medicinal products (ATMPs). "By lowering the GMP requirements for ATMPs, the European Commission is not only exposing patients to an increased risk t...
  • Regulatory NewsRegulatory News

    European Commission Unveils Four New Public Consultations on Clinical Trials

    The four new consultations, released Thursday from the European Commission, deal with ethical considerations for pharmaceutical trials with minors, risk proportionate approaches in trials, summaries of trial results for non-specialists or “laypersons” and definitions of investigational medical products (IMPs) and use of auxiliary medicinal products (AMPs). The consultations offer respondents a chance to weigh in (comments on the four consultations are due by 31 August) o...
  • Regulatory NewsRegulatory News

    Regulators, Industry Weigh in on Proposed EU Orphan Regulation Changes

    As the number of orphan drug approvals continues to rise in the EU, the European Commission is now considering feedback from European governments, regulators and industry on how changes to five aspects of the Orphan Regulation may further incentivize the development of drugs for rare diseases. To date, the commission has authorized 117 orphan medicines, 82% of which consist of new active substances, according to a new report .  And while the number of products authorize...
  • Regulatory NewsRegulatory News

    Public Comment Period Opens on ISO 9001, Major Device Quality Standard

    The International Standards Organization (ISO), an international group whose standards are widely used in the life sciences industry, has finally released a draft of its latest iteration of the ISO 9001 standard for public consultation. Background The standard, which covers Quality Management Systems (QMS), undergoes  a revision process once every five years, and was last updated in 2008 (ISO 9001:2008). The ISO 9001 standard is used extensively throughout the medical...
  • Brazil Opens Consultation on API Manufacturing Change Notifications

    Brazil's National Agency for Sanitary Surveillance (Anvisa) opened a public consultation (Consultation No. 22/13) on 12 July 2013 concerning new requirements for reporting manufacturing changes for active pharmaceutical ingredients (APIs). The proposal provides a classification system as to the types of possible changes and the reporting procedures that should be adopted in each case. The manufacturer would have to notify Anvisa of changes according to the impact on t...
  • Changes Coming to Australian Advertising Rules

    Australia's Therapeutic Goods Administration (TGA) has opened a consultation on proposed changes to the current regulatory framework for the advertising of therapeutic goods to the general public. The TGA noted that it is not proposing any changes relating to the advertising of prescription and certain pharmacist-only medicines to the general public, which will remain prohibited in Australia. The objectives of the proposed reforms are to: Improve the timeliness and ...
  • TGA Opens Consultation on Rolling Adoption’ of PIC/S GMP Changes

    Australia's Therapeutic Goods Administration (TGA) has opened a consultation on implementing a 'rolling adoption' of new good manufacturing practice (GMP) versions of the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S), two international instruments designed to improve co-operation between regulatory authorities and the pharmaceutical industry. The proposal would automatically adopt the new PIC/S changes during a transition p...
  • Brazil Opens Consultation on 2013-14 Regulatory Agenda

    Brazil's National Health Surveillance Agency (Anvisa) has opened up its 2013-2014 Regulatory Agency for public consultation and comments, it announced this week. The Preliminarily Proposed Themes were developed through discussions held within the agency and target 78 regulatory measures of which 63% were continued from the 2012-2013 Agenda.  The consultation is open to so-called participating entities that are qualified according to the following criteria: an ...