• Regulatory NewsRegulatory News

    With Eye on Improving Quality, Indian Regulator gets First ISO Certification

    India’s regulatory authority has announced that one of its offices has become the first in the country to become certified by the International Organization for Standardization (ISO). In a press release, the Central Drugs Standard Control Organization (CDSCO) said that its Ahmedabad office received ISO 9001:2008 certification for its quality management system (QMS) on 16 February 2015. Background ISO 9001 is a set of standards for QMS in organizations where it is imp...
  • Regulatory NewsRegulatory News

    How Does the Pharmaceutical Industry Really Work? FDA Wants its Managers to Know

    The Center for Drug Evaluation and Research (CDER) has announced that it plans to continue a program which allows pharmaceutical companies to invite regulators to visit their manufacturing sites to better understand how the industry operates. Background The program, known as the Regulatory Project Management Site Tours and Regulatory Interaction Program, or the "Site Tours" program, has been in effect in various forms since 1999, when it was created by CDER's Training a...
  • Regulatory NewsRegulatory News

    Another Reorganization for CDER: Its Office of Management

    The US Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is already off to a busy start this year, having released new long-sought functions on its website , launched its new Office of Pharmaceutical Quality (OPQ) and hired a permanent director for its Office of Generic Drugs . The changes, it seems, aren't stopping there. Last week, CDER also announced a reorganization of its Office of Management in the hopes of streamlining its approach ...
  • Regulatory NewsRegulatory News

    EMA Scrambles to Consider Options After Leader Ousted

    Members of the European Medicines Agency (EMA) met last week to consider an unprecedented question: How should they select a new, permanent leader after they were forced to fire the last one? Background On 13 November 2014, the EU Civil Service Tribunal found that Guido Rasi, then EMA's executive director of three years, had been appointed through an improper selection process and that his appointment would be annulled. At the time, a seemingly stunned EMA said ...
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    ANVISA to Allow Medical Device Firms to Evaluate Their Inspections

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Brazilian medical device regulator ANVISA has begun accepting  feedback  from medical device companies subject to quality management inspections in order to improve and standardize inspection processes. Firms inspected for Brazilian Good Manufacturing Practice (BGMP) compliance now have the option of submitting a form to ANVISA prov...
  • 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...
  • Regulatory NewsRegulatory News

    FDA Quietly Announces Creation of New Regulatory Division, Search Begins for Leader

    The US Food and Drug Administration (FDA) is looking to hire a high-level regulatory official to lead the agency's brand new division of Regulatory Affairs Strategic Management (RASM), it announced this week. The position, for a deputy associate commissioner, was recently created "to respond to significant changes in the regulated industry" and FDA's scope of authority, the agency said in its job posting for the position. Explained FDA: "These changes includ...
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    EMA Re-Elects Former MHRA Regulator to Lead Influential Management Board

    The European Medicines Agency (EMA) has announced the re-election of Sir Kent Woods as the chair of its influential 35-member Management Board, which sets regulatory policies for the agency. Woods, who served as chief executive at the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) between 2004 and 2013 , will now serve as the board's chair for a final three-year term, after which time term limits preclude him from running again. Woods said in ...
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    EMA Adopts Changes to Trials Transparency Policy, October 2014 Start Date Predicted

    The European Medicines Agency's (EMA) management board has signed off on the regulator's clinical trials transparency policy, adopting several changes along the way the regulator said would make the data the policy is intended to provide access to "more user-friendly." Background As Focus explained earlier this week , EMA has for years been seeking a policy by which it could release patient-anonymized clinical trials data used to support drug approvals to the p...
  • Feature ArticlesFeature Articles

    Creating a Culture of Compliance

    In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis. This focus creates a culture that views compliance as a positive, critically important part of the business. In fact, a recent study sho...
  • In Transparency Bid, EU Regulators Unleash More Information About Drug Safety Measures

    In the EU, as in the US, regulators often approve medicines along with measures intended to mitigate risks associated with the use of a drug. Background: What's an RMP? The Risk Management Plans (RMPs), as they're called, include information on how to minimize or prevent risk, plans to initiate postmarketing studies on the safety and efficacy of a medicine, studies to measure the effectiveness of risk-mitigation measures, and general information regarding the known r...
  • FDA to Continue Regulatory Training Program That Brings Together Regulators and Industry

    US pharmaceutical regulators have announced that they will continue a regulatory program that allows companies to invite officials from the Center for Drug Evaluation and Research (CDER) into their facilities to learn more about how the industry works. Background: Site Tours Program The program, known as the Regulatory Project Management Site Tours and Regulatory Interaction Program, or the Site Tours Program, has been in effect in various forms since 1999 when it was c...