Global Regulatory News

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1 Online Exclusive from PHARMACEUTICAL ENGINEERING THE OFFICIAL TECHNICAL MAGAZINE OF ISPE JANUARY/FEBRUARY 2015, VOL 35, NO 1 Copyright ISPE regulatory compliance Global Regulatory News Asia/Pacific Rim Australia TGA Issues Business Plan The TGA Business Plan , which can be found at: tga.gov.au/publication/tga-businessplan , provides an overview of the organisation s strategic considerations including the mission, key roles and responsibilities, priorities and areas of particular emphasis, and significant changes and challenges. International Efforts Cease to Establish a Joint Therapeutic Products Regulator 1 The Hon. Peter Dutton MP, Minister for Health for Australia, and the Hon. Dr. Jonathan Coleman, Minister of Health for New Zealand, announced their governments agreement to cease efforts to establish a joint therapeutic products regulator, the Australia New Zealand Therapeutic Products Agency (ANZTPA). The decision was made following a comprehensive review of progress and assessment of the costs and benefits to each country of proceeding. While work on ANZTPA will cease, the two countries will continue to cooperate on the regulation of therapeutic products where there are mutual benefits for consumers, businesses and regulators in each country. Chinese FDA and US FDA Sign Cooperation Document 2 On 21 November 2014, Wu Zhen, Vice Minister of China Food and Drug Administration (CFDA) met with the delegation headed by Dr. Margaret Hamburg, Commissioner of the US Food and Drug Administration (FDA). Both sides exchanged opinions on topics of common concerns such as further deepening of China-US cooperation in drug supervision, mutual cooperation and support in relevant international organizations, and the exchange of regulatory staff. After the meeting, Wu Zhen and Margaret Hamburg signed the Implementing Arrangement between the Food and Drug Administration of the Department of Health and Human Services of the United States of America and the China Food and Drug Administration of the People s Republic of China regarding the cooperative mechanism of regulatory staff. Exchange of regulatory staff between the two countries will contribute to ensure food and drug safety for both countries and boosting exchanges and cooperation between both sides in the field of supervision. ICH News from the ICH Steering Committee 3 The Steering Committee (SC) agreed on the key issues relating to the reform of ICH in terms of governance, new membership and funding. ICH remains committed to enhanced communication, transparency and the openness of ICH to all relevant stakeholders. The SC will now proceed with finalizing the Articles of Association and funding model that will allow the ICH parties to carry out their internal consultations, which will pave the way toward establishing ICH as a legal entity as an international association under Swiss law. Membership in the Assembly, which will be the overarching body of the Association, will be established as soon as the legal entity has been set up. TGA Upgrades Website 5 TGA has implemented a new search engine and has improved navigation on the TGA website. All the website content will still be available, but it will now be easier to find. Expert Review of Medicines and Medical Devices Regulation 6 The Australian Government is planning a review of the regulation of medicines and medical devices. The Review will be conducted by a panel of three experts: Emeritus Professor Lloyd Sansom AO, Will Delaat AM, and Professor John Horvath AO. The Review will examine specific aspects of the regulatory framework for medicines and medical devices administered by the Therapeutic Goods Administration with a view to identifying: Areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia. Opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods. PHARMACEUTICAL ENGINEERING JANUARY/FEBRUARY

2 China CFDA Issues the Third Supplement to Chinese Pharmacopeia (2010 Edition) 7 The China Food and Drug Administration (CFDA) has issued the Third Supplement to the Chinese Pharmacopeia (2010 edition) that will go into force as of 1 February The Third Supplement makes improvements in testing technology, impurity control and other aspects. Japan Revision of the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics 8 Major points of the amendments to the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics include: 1. Harmonizing the 2nd chapter of the ordinance with ISO13485: Describing the additional requirements to ISO13485:2003 in the 3rd chapter of the ordinance Singapore Health Sciences Authority Proposes Subsidiary Legislation for the Transfer of Controls of Pharmaceutical Products to Health Products Act 9 Currently, the legislative controls for pharmaceutical products are covered under different Acts, namely the Medicines Act (Cap. 176) and Poisons Act (Cap. 234). Consolidating the relevant controls under the HPA will provide greater clarity to stakeholders as they would only need to refer to a single legislation. Europe European Union EMA Releases Practical Guidance on Access-to-Documents Requests 10 The European Medicines Agency (EMA) has released a practical guide detailing the process for requesting access to unpublished documents held by the Agency. The guide details in particular: How a request is processed How the documents are provided In which cases access can be refused How a requester can appeal EMA s decision to refuse access to documents EMA Management Board Discusses Next Steps after Judgment of EU Civil Service Tribunal 11 The European Medicines Agency s (EMA) Management Board held a meeting on 27 November 2014 in Rome, Italy to discuss the consequences of the judgment by the European Union Civil Service Tribunal that annulled the appointment of the Agency s Executive Director Guido Rasi. The Management Board chaired by Sir Kent Woods confirmed that Deputy Executive Director Andreas Pott will be in charge of the management and operations of the Agency until the new selection procedure suggested by the European Commission is finalized. The European Commission plans to publish a vacancy announcement for the post of Executive Director shortly. EMA Releases Practical Guidance on Access-to-Documents Requests 12 The European Medicines Agency (EMA) has released a practical guide detailing the process for requesting access to unpublished documents held by the Agency. As foreseen by European Union law and detailed in the EMA s 2010 access-to-documents policy, citizens can have access to documents held by EMA. The guidance can be found at: jsp?curl=pages/news_and_events/ news/2014/11/news_detail_ Conflicts of Interest: Revised EMA Policy Reflects More Balanced Approach 13 The European Medicines Agency (EMA) has published its revised policy on handling declarations of interests for scientific committee members and experts. The revisions reflect a more balanced approach to handling conflicts of interests that aims to effectively restrict the involvement of experts with possible conflicts of interests in the Agency s work while maintaining EMA s ability to access the best available expertise. The revised policy, which was endorsed by the EMA Management Board in March 2014, takes into account input from stakeholders at the Agency s September 2013 public workshop Best expertise vs conflicts of interests: striking the right balance. United Kingdom Professor Sir Michael Rawlins appointed Chair of Medicines and Healthcare Products Regulatory Agency 14 The Medicines and Healthcare Products Regulatory Agency has appointed Professor Sir Michael Rawlins as its new Chair effective 1 December 2014 and his appointment will be for three years. Professor Sir Michael assumes the role from Sir Gordon Duff who announced his intention to step down earlier this year, following his election as Principal of St Hilda s College, Oxford. Professor Sir Michael Rawlins was until recently Chair of the National Institute of Health and Clinical 2 JANUARY/FEBRUARY 2015 PHARMACEUTICAL ENGINEERING

3 Excellence (NICE), a role from which he stood down in He is also currently Chairman of Biobank. North America United States FDA Issues Three Policy Documents on Compounding of Sterile Drugs 15 The FDA has issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents also will assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November The new guidance documents are: Final guidance on registration of human drug compounding outsourcing facilities under section 503B of the FD&C Act. This final guidance assists compounding facilities that decide to register as outsourcing facilities with the logistics of registering with the FDA, and the process for registering, re-registering, and de-registering. Final guidance on fees for human drug compounding outsourcing facilities under sections 503B and 744K of the FD&C Act. This final guidance provides information about the fees that a facility must pay to register as an outsourcing facility; how facilities can submit payment to the FDA; the consequences of failure to pay fees; and how a facility can qualify as a small business to obtain a reduction in registration fees. The guidance also provides information on fees that may be assessed for reinspection of outsourcing facilities. Revised draft guidance on electronic drug product reporting for human drug compounding outsourcing facilities under section 503B of the FD&C Act. This revised draft guidance provides information about the electronic submission of drug product reports to the FDA for registered outsourcing facilities. Upon initial registration as an outsourcing facility and twice each year, registrants must electronically submit a drug product report to the FDA. This report must identify all drugs compounded by the outsourcing facility during the previous six-month period and provide certain information for each compounded drug. The draft guidance on electronic drug product reporting is available in the Federal Register for public comment for 60 days. FDA Publishes Guidance on Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture 16 This guidance provides recommendations intended to assist in determining which reporting mechanism is appropriate for submission of changes to an approved Biologics License Application (BLA) in accordance with the requirements under Title 21 of the Code of Federal Regulations (CFR) (21 CFR ), including recommendations in connection with the applicability and content of comparability protocols under 21 CFR (e) and labeling changes under 21 CFR (f). This guidance finalizes the draft guidance of the same title dated June 2013 (78 FR 32668, May 31, 2013) and supersedes the guidance entitled, Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture dated July 2001 (66 FR 41247, August 7, 2001). FDA Releases Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection 17 The Food and Drug Administration Safety and Innovation Act added a provision to the Food, Drug, and Cosmetic Act concerning inspections that makes a drug adulterated. This guidance defines the types of actions, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated. FDA Updates Information on Postmarket Drug Quality Sampling and Testing Programs 18 Every year, the FDA monitors and tests hundreds of drug products and active pharmaceutical ingredients to help ensure safe, effective and high-quality products are available to consumers. The FDA has posted regarding postmarket drug quality sampling and testing programs to provide product safety and effectiveness test results to health care professionals and consumers. More information can be found on FDA s Drug Quality Sampling and Testing page at FDA Issues Draft Guidance for Industry: The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers 19 The FDA is issuing this guidance to assist stakeholders in understanding the effects of section 585 (Uniform National Policy) of the Food Drug and Cosmetic Act, which was added by the Drug Supply Chain Security Act (DSCSA). The DSCSA establishes a Federal system for tracing pre- PHARMACEUTICAL ENGINEERING JANUARY/FEBRUARY

4 scription drug products through the pharmaceutical distribution supply chain. It also requires FDA to establish federal standards for licensing of wholesale drug distributors and third party logistics providers. Section 585 sets forth a uniform national policy preempting states from establishing or continuing in effect certain standards and requirements related to prescription drug product tracing and licensing, wholesale distributors and third-party logistics providers. Guidance on Critical Path Innovation Meetings 20 This draft guidance, which can be found at: loads/drugs/guidancecompliance- RegulatoryInformation/Guidances/ UCM pdf, describes a Critical Path Innovation Meeting (CPIM), a means by which FDA s Center for Drug Evaluation and Research (CDER) and investigators from industry, academia, government, and patient advocacy groups can communicate to improve efficiency and success in drug development. The goals of the CPIM are to discuss a methodology or technology proposed by the meeting requester and for CDER to provide general advice on how this methodology or technology might enhance drug development. The discussions and background information submitted through the CPIM are nonbinding on both FDA and CPIM requesters. FDA Issues Final Rule on Changes to Pregnancy and Lactation Labeling Information for Prescription Drug and Biological Products 21 The US Food and Drug Administration published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding. FDA s Program Alignment Addresses New Regulatory Challenges References 22 In a blog post, FDA Commissioner Margaret Hamburg outlined challenges facing the FDA and an effort of Program Alignment to meet these challenges. The challenges include an increased breath and complexity of FDA s mandate, the impact of globalization on supply chains, and the rapid scientific innovation and increased biomedical diversity. The Directorates, Centers and the Office of Regulatory Affairs (ORA) have collaborated closely to define the changes needed to align the Agency more strategically and operationally and meet the greater demands placed on it. Each regulatory program has defined new action plans which will provide focus for the year 2015, and in some cases require additional 5 year plans to be developed. For more information, see: gov/fdavoice/index.php/2014/10/ fdas-program-alignment-addressesnew-regulatory-challenges/. FDA Announces Fiscal Year 2015 Regulatory Science Priorities under the Generic Drug User Fee Amendments (GDUFA) of The FDA has published the fiscal year 2015 regulatory science priorities for generic drugs. The FY 2015 research priorities list was prepared based on comments received at the 16 May 2014, public meeting, comments submitted to the public docket, scientific issues raised in citizen petitions, meeting request and controlled correspondence topics, tracked safety issues and discussions within FDA s Center for Drug Evaluation and Research. To comply with this GDUFA requirement, the FDA Office of Generic Drugs developed the following fiscal year 2015 regulatory science priorities for generic drugs: Post-market evaluation of generic drugs Equivalence of complex products Equivalence of locally-acting products Therapeutic equivalence evaluation and standards Computational and analytical tools SUPAC: Manufacturing Equipment Addendum Guidance for Industry 24 This guidance combines and supersedes the following Scale-Up and Post-Approval Changes (SUPAC) guidances for industry: (1) SUPAC-IR/ MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum, and (2) SUPAC-SS Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum. It removes the lists of manufacturing equipment that were in both guidances and clarifies the types of processes being referenced. A draft guidance, SUPAC: Manufacturing Equipment Addendum, was published on April 1, Comments were received and changes were made to address those comments. References 1. Australian Department of Health, Content/health-mediarel-yr2014- dutton100.htm. 2. China Food and Drug Administration, WS03/CL0757/ html. 3. ICH, press-release-ich-steering-committee-meeting-in-lisbon-november-2014.html. 4. Australian Therapeutic Goods Administration, gov.au/publication/tga-businessplan JANUARY/FEBRUARY 2015 PHARMACEUTICAL ENGINEERING

5 5. Australian Therapeutic Goods Administration, gov.au/upgrade-tga-website. 6. Australian Therapeutic Goods Administration, au/media-release/expert-reviewmedicines-and-medical-devicesregulation#.ve_xcpnf_gg. 7. China Food and Drug Administration, WS03/CL0757/ html. 8. Japanese Ministry of Health, Labour, and Welfare, mhlw.go.jp/english/policy/healthmedical/pharmaceuticals/qms. html. 9. Singapore s Health Sciences Authority, sg/content/hsa/en/news_events/ Press_Releases/2014/hsa-seeksviewsproposedadvert-pharmacylicensing.html. 10. European Medicines Agency, news_and_events/news/2014/11/ news_detail_ European Medicines Agency, news_and_events/news/2014/12/ news_detail_ European Medicines Agency, news_and_events/news/2014/11/ news_detail_ European Medicines Agency, news_and_events/news/2014/11/ news_detail_ British Medicines and Healthcare Products Regulatory Agency Centre/Pressreleases/CON US Food and Drug Administration, ucm pdf. 16. US Food and Drug Administration, Guidances/Blood/ucm htm. 17. US Food and Drug Administration, guidances/ucm pdf. 18. US Food and Drug Administration, ScienceResearch/ucm htm. 19. US Food and Drug Administration, US Food and Drug Administration, developmentapprovalprocess/ druginnovation/ucm htm. 21. US Food and Drug Administration, NewsEvents/Newsroom/PressAnnouncements/ucm htm. 22. US Food and Drug Administration, fdavoice/index.php/2014/10/ fdas-program-alignment-addresses-new-regulatory-challenges/. 23. US Food and Drug Administration, pdf. 24. US Food and Drug Administration, PHARMACEUTICAL ENGINEERING JANUARY/FEBRUARY

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