CANADA (HEALTH CANADA)

Transcription

1 LEADERS 1 THE GMP GAZETTE TM February 2015 HPFBI CANADA (HEALTH CANADA) Blood Establishment Registration Application: Form and Instructions - (FRM-0353) Who s affected? Anyone who plans to perform the following activities requires a Blood Establishment Registration (BER): Collection of autologous blood; Component preparation of autologous blood; Have a Pre-Assessed Donor Program; and/or Transformation of blood. What s the impact? Stakeholders can obtain an electronic copy of the Blood Establishment Registration Application Form and the Frequently Asked Questions - Blood Establishment Licensing and Registration by sending a request to blood_sang_questions@hc-sc.gc.ca, with subject line: "Request for BER Form and FAQs. Posting date: January 29, 2015 Blood Establishment Licensing Application Form and Instructions - (FRM-0354) Who s affected? Anyone who plans to perform the following activities requires a Blood Establishment Licence (BEL): Processing allogeneic blood, except as part of a pre-assessed donor program; o "Processing" is defined as donor suitability assessment, collection, testing, or blood component preparation Importing blood; and/or Testing blood from a pre-assessed donor.

2 LEADERS 2 What s the impact? Stakeholders can obtain an electronic copy of the Blood Establishment Licence Application Form and the Frequently Asked Questions - Blood Establishment Licensing and Registration by sending a request to blood_sang_questions@hc-sc.gc.ca, with subject line: "Request for BEL Forms and FAQs". Posting date: January 29, 2015 NNHPD NHPs Consultation - New and Revised Monographs (Mushrooms, Poria - Wolfiporia extensa and Maitake - Grifola frondosa) Adult use only New Monograph: Mushrooms January 20, 2015 Revised Monographs: Poria Wolfiporia extensa January 20, 2015 Maitake Grifola frondosa January 20, 2015 Who s affected? All potential applicants wishing to submit NHP applications including the above ingredients. Current licence holders should review their products for compliance with the revised monographs. What s the impact? The NNHPD is seeking comments from industry on the new and revised monographs from January 20, 2015, to February 18, The information is available at the above web-link. Posting date: January 20, 2015 DISINFECTANTS

3 LEADERS 3 Consultation Revised Monograph (Hard Surface Disinfectants Monograph) The monograph has been revised: Hard Surface Disinfectants Monograph January 7, 2015 Who s affected? All potential applicants wishing to submit drug applications that include drug ingredients listed in the revised monograph The NNHPD intends to combine the existing Hard Surface Disinfectant monograph (February 2014) and the Toilet Bowl Disinfectant Cleaners (February 2014) monograph into a single Hard Surface Disinfectants Monograph. Applicants may add additional information to their product labels, outside of what is specified in the monograph. The additional information (e.g. nontherapeutic claims) must not be false, misleading or likely to create an inaccurate impression of the product. In addition, the information must be consistent with the labelling recommendations outlined in the following Guidance Documents: Disinfectant Drugs Safety and Efficacy Requirements for Hard Surface Disinfectant Drugs What s the impact? The NNHPD is seeking comments from industry on the proposed monograph from January 27, 2015 to February 6, The information is available at the above web-link. Potential applicants should review the upcoming changes and consult the Management of Disinfectant Drug Applications, Disinfectant Drugs and Safety and Efficacy Requirements for Hard Surface Disinfectant Drugs Guidance Documents. Applicants should also consult section 2.4 of the Guidance Document Disinfectant Drugs to obtain information about the labelling requirements for disinfectant products. Posting date: January 7, 2015 NON-PRESCRIPTION DRUGS No updates

4 LEADERS 4 TPD COSMETICS No updates DRUGS No updates MEDICAL DEVICES Notice: Update on the Medical Device Single Audit Program (MDSAP) Pilot and the Participation of Medical Device Manufacturers Health Canada is asking Class II, III and IV medical device manufacturers to participate in the 3 year Medical Devices Single Audit Program (MDSAP) Pilot which began on January 1, The MDSAP will ensure a single internationally recognized audit of the quality management system for medical devices, covering existing quality system requirements for Canada (ISO13485:2003), Brazil (RDC ANVISA 16/2013) and the USA (21 CFR 820). Additionally, the MDSAP will cover requirements from regulatory authorities in relation to registration, licensing, advisory notices / recalls and mandatory problem reporting. The MDSAP will replace the current Canadian Medical Device Conformity Assessment System (CMDCAS) program at the end of the pilot. Thus, while CMDCAS and MDSAP certificates are currently accepted by Health Canada, at the end of the pilot only MDSAP certificates from Health Canada recognized registrars will be accepted. The list of Registrars recognized by Health Canada can be found on the Health Canada website. Questions on the MDSAP may be directed to QS_MDB_HC@hc-sc.gc.ca.

5 LEADERS 5 Who s affected? Class II, III and IV medical device manufacturers What s the impact? MDSAP implementation will allow a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions for the medical device manufactures making it easy to get approval in different jurisdictions. Posting date: January 16, 2015 CDER DRUGS Guidance for Industry, S10 Photosafety Evaluation of Pharmaceuticals USA (FDA) Who s affected? Applicants planning to submit new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics licence applications (BLAs), and investigational new drug applications (INDs) to CDER or CBER This guidance: Recommends international standards for photosafety assessment, and harmonizes such assessments that support human clinical trials and marketing authorizations for pharmaceuticals Includes factors for initiation of and triggers for additional photosafety assessment Should be read in conjunction with ICH M3(R2), section XIV(14) on photosafety testing Applies to new active pharmaceutical ingredients (APIs), new excipients, clinical formulations for dermal application (including dermal patches), and photodynamic therapy products What s the impact? Contains non-binding recommendations unless specific regulatory or statutory requirements are cited. Stakeholders may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. Issued date: January 26, 2015

6 LEADERS 6 Draft Guidance for Industry & FDA Staff, Current Good Manufacturing Practice Requirements for Combination Products Who s affected? Manufacturers of combination products This draft guidance: Describes and explains the final rule (as codified in 21 CFR part 4) on cgmp requirements for combination products that FDA issued on January 22, 2013 o Combination products consist of a combination of drugs, devices, biological products, and/or Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) What s the impact? For comment purposes only. Comments must be submitted either electronically or in writing to the FDA by March 30, 2015 to ensure the Agency considers them before beginning on the final version. Issued date: January 27, 2015 CBER VACCINES & BIOLOGICS Guidance for Industry, S10 Photosafety Evaluation of Pharmaceuticals Who s affected? Applicants planning to submit new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics licence applications (BLAs), and investigational new drug applications (INDs) to CDER or CBER This guidance: Recommends international standards for photosafety assessment, and harmonizes such assessments that support human clinical trials and marketing authorizations for pharmaceuticals Includes factors for initiation of and triggers for additional photosafety assessment Should be read in conjunction with ICH M3(R2), section XIV(14) on photosafety testing Applies to new active pharmaceutical ingredients (APIs), new excipients, clinical formulations for dermal application (including dermal patches), and photodynamic therapy products

7 LEADERS 7 What s the impact? Contains non-binding recommendations unless specific regulatory or statutory requirements are cited. Stakeholders may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. Issued date: January 26, 2015 Draft Guidance for Industry & FDA Staff, Current Good Manufacturing Practice Requirements for Combination Products Who s affected? Manufacturers of combination products This draft guidance: Describes and explains the final rule (as codified in 21 CFR part 4) on cgmp requirements for combination products that FDA issued on January 22, 2013 o Combination products consist of a combination of drugs, devices, biological products, and/or Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) What s the impact? For comment purposes only. Comments must be submitted either electronically or in writing to the FDA by March 30, 2015 to ensure the Agency considers them before beginning on the final version. Issued date: January 27, 2015 CFSAN COSMETICS No updates DIETARY SUPPLEMENTS

8 LEADERS 8 No updates CDRH MEDICAL DEVICES Draft Guidance for Industry & FDA Staff, Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types Who s affected? Manufacturers of devices that are considered accessories as defined by the FDA This draft guidance: Is intended to clarify and modify FDA s policy concerning the classification of accessories Discusses the application of that policy to specific categories of devices that are commonly used as accessories to other medical devices Encourages utilization of the de novo classification process under Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to allow manufacturers and other parties to request risk-based classification of accessories of a new type [i.e., accessories of a type that has not been previously classified under the FD&C Act or approved in an application for premarket approval (PMA)]. What s the impact? For comment purposes only. Comments must be submitted either electronically or in writing to the FDA by April 20, 2015 to ensure the Agency considers them before beginning on the final version. Issued date: January 20, 2015 Draft Guidance for Industry and FDA Staff, General Wellness: Policy for Low Risk Devices Who s affected? Manufacturers of general wellness products as defined by the FDA This draft guidance:

9 LEADERS 9 Provides clarity to industry on the compliance policy for low risk products that promote a healthy lifestyle (general wellness products) Does not apply to products (e.g., drugs, biologics, dietary supplements, foods, or cosmetics) regulated by other FDA Centers or to combination products, including those regulated by CDRH o CDRH does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devices under the FD&C Act and implementing regulations What s the impact? For comment purposes only. Comments must be submitted either electronically or in writing to the FDA by April 20, 2015 to ensure the Agency considers them before beginning on the final version. Issued date: January 20, 2015 Draft Guidance for Industry & FDA Staff, Current Good Manufacturing Practice Requirements for Combination Products Who s affected? Manufacturers of combination products This draft guidance: Describes and explains the final rule (as codified in 21 CFR part 4) on cgmp requirements for combination products that FDA issued on January 22, 2013 o Combination products consist of a combination of drugs, devices, biological products, and/or Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) What s the impact? For comment purposes only. Comments must be submitted either electronically or in writing to the FDA by March 30, 2015 to ensure the Agency considers them before beginning on the final version. Issued date: January 27, USP (GENERAL CHAPTERS) <121> Insulin Assay

10 LEADERS 1 Revision of USP Reference Standards; and Standard stock solution preparation Official date: March 1, 2015 Posting date: January 30, <87> Biological Reactivity, In Vitro General chapter is being revised to remove the reference to the USP Positive Bioreaction RS and will include a reference to an alternate Positive Control that is suitable. This change is due to the inability to acquire the material needed for the replacement lot. Polyurethane film containing Zinc Diethyldithiocarbamate (ZDEC) and Zinc Dibythyldithiocarbamate (ZDBC) from Hatano Research Institute was identified and determined to be suitable as a Positive Control. Target official date: September 1, 2015 Posting date: January 30, 2015