CANADA (HEALTH CANADA)

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1 1 GMP GAZETTE TM May 2016 HPFBI CANADA (HEALTH CANADA) No updates NNHPD NHPs Final Monograph for Antiseptic Skin Cleanser Who`s Affected? Companies seeking NPN or DIN for topical antiseptic hand cleansers intended for domestic/personal care use. Official monograph for Antiseptic Skin Cleanser for domestic/personal care use What`s the Impact? Stakeholders must be aware of the content of this Monograph to ensure their PLAs are accepted.

2 2 Posted Date: February 09, 2016 Effective Date: February 09, 2016 The Non Prescription and Natural Health Products Directorate is moving new physical and mailing addresses Who`s Affected? All companies seeking product or site license from NNHPD. For the following, refer to the addresses listed at"contact Us" : Mail / Courier of Product License Applications Mail / Courier of Site License Applications Clinical Trial Applications Trading Partner Enrolment Packages Consultations Product Classifications General Enquiries Technical Issues and/or Errors with Forms/Databases What`s the Impact? NNHPD will not be responsible for the applications sent to the wrong address after May 06, Both physical and addresses have been updated. Posted Date: April 14, 2016 Effective Date: May 06, 2016 DISINFECTANTS

3 3 No updates NON PRESCRIPTION DRUGS No Updates TPD COSMETICS No updates DRUGS Revised: Guidance Document: Preparation of Drug Regulatory Activities in the "Non ectd Electronic Only" Format Who`s Affected? All drug manufacturers performing regulatory submissions of any purpose (Defined in Scope and Application section of the guidance document) This Document:

4 4 Is a revision to the Guidance Document: Preparation of Drug Regulatory Activities in the "Non ectd Electronic Only" Format, published in September 2015, and now includes Division 8 drugs and Clinical Trial regulatory activities in "non ectd electronic only" format Contains the provision for electronics submission of the regulatory activity/transaction where the ectd format is not accepted by Health Canada Outlines the dates for phasing out paper submissions for certain regulatory purposes of Division 1, Division 5, Division 8, DSUR, PV Data,, Level III and DMF Details the structure and content of the document for the applicable regulatory activity What`s the impact? Paper will no longer be accepted as of June 1st, 2016 for Division 5 and Division 8. By March 31, 2016, all existing DMFs in paper format must be replaced by a complete DMF conversion in an electronic only format. Posting Date: February 03, 2016 Q9: Quality Risk Management Who s affected? All GMP manufacturers engaged with development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug (medicinal) products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging and labeling materials in drug (medicinal) products, biological and biotechnological products). Health Canada has announced the adoption of ICH Q9: Quality Risk Management. In order to fulfill the commitment to internationally harmonized practices, Health Canada has adopted yet another ICH guidance document. In the circumstances where subject matter of current Health Canada guidances may not be entirely consistent with those of the ICH, Health Canada adopted ICH guidelines will take precedence. What`s the Impact? While the current Health Canada requirements still remain in effect, Health Canada will acknowledge the implementation of the Risk Management as per ICH Q9 as equivalent to their own. Health Canada has committed to eliminate any discrepancies via amendment and/or withdrawal. Posted Date: February 05, 2016

5 5 Effective Date: February 05, 2016 Q8(R2): Pharmaceutical Development Who s affected? Companies preparing GMP Drug Product and Biological Product regulatory submissions ICH Q8 (R2) guideline describes the suggested contents for 3.2.P.2 section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. In order to fulfill the commitment to an internationally harmonized practices, Health Canada has adopted yet another ICH guidance document. In the circumstances where subject matter of current Health Canada guidances may not be entirely consistent with those of the ICH, Health Canada adopted ICH guidelines will take precedence. What`s the Impact? While the current Health Canada requirements still remain in effect, the Health Canada will acknowledge the use of ICH Q8(R2): Pharmaceutical Development, for submission purposes, as equivalent to their own. Health Canada has committed to eliminate any discrepancies via amendment and/or withdrawal. Posted Date: February 11, 2016 Effective Date: February 11, 2016 Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Who s affected? Companies preparing GMP Drug Substance and Biological Entities regulatory submissions ICH Q11 describes developing and understanding the manufacturing process of the drug substance It also has guidance on what information should be provided in Module 3 of the Common Technical Document (CTD) Sections 3.2.S S.2.6 (ICH M4Q).

6 6 In order to fulfill the commitment to internationally harmonized practices, Health Canada has adopted yet another ICH guidance document. In the circumstances where subject matter of current Health Canada guidances may not be entirely consistent with those of the ICH, Health Canada adopted ICH guidelines will take precedence. What`s the Impact? While the current Health Canada requirements still remain in effect, Health Canada will acknowledge the use of ICH Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) for submission purposes, as equivalent to their own. Health Canada has committed to eliminate any discrepancies via amendment and/or withdrawal. Posted Date: February 11, 2016 Effective Date: February 11, 2016 Q10: Pharmaceutical Quality System Who s affected? Companies developing and manufacturing pharmaceutical drug substances (APIs) and drug products, biotechnology and biological products ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system which can be implemented throughout the different stages of product lifecycle. In order to fulfill the commitment to internationally harmonized practices, Health Canada has adopted yet another ICH guidance document. In the circumstances where subject matter of current Health Canada guidances may not be entirely consistent with those of the ICH, Health Canada adopted ICH guidelines will take precedence. What`s the Impact? While the current Health Canada requirements still remain in effect, Health Canada will acknowledge the use of ICH Q10: Pharmaceutical Quality System throughout the product lifecycle, as equivalent to their own. Health Canada has committed to eliminate any discrepancies via amendment and/or withdrawal. Posted Date: February 16, 2016 Effective Date: February 16, 2016

7 7 Notice: Guidance Document: Tamper resistance Formulations of Opioid Drug Products Who`s Affected? Sponsors seeking to obtain approval for controlled release opioid drug formulations with tamper resistant properties. This guidance: Provides guidance to sponsors seeking Notice of Compliance (NOC) with the claim of a tamper resistant formulation containing opioid drug products. Includes criteria and data requirement for pre market studies Has information regarding what is required for the Product Monograph What`s the impact? Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches, supported by adequate justification, should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met. Posted Date: March 30, 2016 Effective Date: March 30, 2016 MEDICAL DEVICES Final Guidance Document: Labelling of In Vitro Diagnostic Devices Medical Devices Who`s Affected? Companies manufacturing, packaging, labelling and marketing in vitro diagnostic devices (IVDDs) This document clarifies the labelling requirements in Sections of the Medical Devices Regulations SOR/ Information was added on e labelling and labelling of smaller containers and blood glucose monitoring systems. What`s the impact? This document replaces the Draft Guidance for the Labelling of In Vitro Diagnostic Devices issued on July 16, 1998 and is effective from April 22, 2016.

8 8 Posting Date: April 22, 2016 Effective Date: April 22, 2016 Consultation Proposed Changes to the Therapeutic Products Directorate's List of Recognized Standards for Medical Devices Who`s Affected? Companies manufacturing, packaging, labelling and marketing Medical Devices Health Canada has posted this Notice of Consultation to provide an opportunity to comment on proposed changes to the therapeutic products directorate`s list of recognized standards for medical devices. The proposed changes consist of: 1) Seven new standards to be added; 2) Two new editions of currently recognized standards added alongside existing versions, with a transition period of three years from the standard's publication date. These standards are: a) IEC :2015 Safety requirements for electrical equipment for measurement, control and laboratory use Part 2 101: Particular requirements for in vitro diagnostic (IVD) medical equipment b) IEC :2014 Medical electrical equipment Part 1 2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances Requirements and tests 3) Nine new editions of currently recognized standards to replace previous editions; 4) Two standards to be removed. What`s the impact? This consultation is open for comments and suggestions until July 2, Refer to the posting for contact numbers and addresses. Posting Date: May 03, 2016

9 9 CDER USA (FDA) DRUGS Draft Guidance for Industry, Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry Who s affected? All Companies involved in any cgmp operations associated with Drug Products, Materials, Biologics and Medical Devices in the United States of America This guidance documents provides much awaited clarity on the FDA`s expectation on Data Integrity and Compliance issues cited during numerous FDA issued 483s in recent years. The key highlights are; o Definition of Data Integrity o Definition of Static and Dynamic Data o Work Flow Validation Expectations for the computer system o cgmp Computer System Restriction Expectations o Audit Trail Review Who, What, How, When o Testing into Compliance with samples usage for System Suitability, Trial, Test, Equilibration Runs What`s the Impact? The draft guidance is open for comments until June 14, Comments can be submitted online, using the following link D Posting Date: April 25, 2016

10 10 Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry Who`s affected? Holders of Type II API DMFs that are or will be referenced in an abbreviated new drug application (ANDA), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions). This guidance makes recommendations about the information that should be included in DMF to facilitate FDA`s mandatory Completeness Assessment (CA) introduced with Generic Drug User Fee Amendments (GDUFA) in o Completeness Assessment by FDA What, How and Why o Outcomes and Interpretation of the CAs What`s the impact? This guidance document is not a legal requirement, it just describes the FDA`s thinking on the topic and hence it should viewed as a recommendation only unless specific regulatory or statutory requirements are cited. Posting Date: February 16, 2016 Who`s affected? All companies submitting application for Biosimilar Products under section 351(k) of the PHS This draft guidance: Provides recommendations on the development of draft labels of prescribing information (package insert) for submission of Biosimilar Products. o When to use Biosimilar Product Name, When to use Reference Product Name, When to use Core name etc. o Specific recommendation on the content of the package insert Includes instructions for initial or revised label submissions What`s the Impact? The draft guidance is open for comments until June 3, Comments can be submitted online use following link D Posting Date : April 04, 2016

11 11 CBER VACCINES & BIOLOGICS Draft Guidance for Industry, Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry Who s affected? All Companies involved in any cgmp operations associated with Drug Products, Materials, Biologics and Medical Devices in the United States of America This guidance documents provides much awaited clarity on the FDA`s expectation on Data Integrity and Compliance issues cited during numerous FDA issued 483s in recent years. The key highlights are; o Definition of Data Integrity o Definition of Static and Dynamic Data o Work Flow Validation Expectations for the computer system o cgmp Computer System Restriction Expectations o Audit Trail Review Who, What, How, When o Testing into Compliance with samples usage for System Suitability, Trial, Test, Equilibration Runs What`s the Impact? The draft guidance is open for comments until June 14, Comments can be submitted online, using the following link D Posting Date: April 25, 2016

12 12 Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry Who`s affected? Holders of Type II API DMFs that are or will be referenced in an abbreviated new drug application (ANDA), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions). This guidance makes recommendations about the information that should be included in DMF to facilitate FDA`s mandatory Completeness Assessment (CA) introduced with Generic Drug User Fee Amendments (GDUFA) in o Completeness Assessment by FDA What, How and Why o Outcomes and Interpretation of the CAs What`s the impact? This guidance document is not a legal requirement, it just describes the FDA`s thinking on the topic and hence it should viewed as a recommendation only unless specific regulatory or statutory requirements are cited. Posting Date: February 16, 2016 CFSAN COSMETICS No updates DIETARY SUPPLEMENTS

13 13 No updates CDRH MEDICAL DEVICES No Updates USP (GENERAL CHAPTERS) USP Publishes new General Chapter <800> Hazardous Drugs Handling in Healthcare Settings Who`s affected? All healthcare personnel (i.e., physicians, nurses, veterinarians, pharmacists and technicians) and all healthcare facilities where hazardous drugs are handled or manipulated, including their storage and distribution. Primary Goal is to prevent and/or limit exposure of hazardous drug to healthcare personnel and/or patients. The standard builds upon several previous publications, including the NIOSH Alert Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings; OSHA Guidelines; ASHP Guidelines on Handling Hazardous Drugs; and the Oncology Nursing Society (ONS) Safe Handling of Hazardous Drugs. What`s the impact? The standard was released on February 01, 2016 and the impacted facilities have until July 01, 2018 to comply with the requirements. The requirements are included as General Chapter <800> in the first supplement of USP 39 NF 34 released on February 01, 2016.

14 14 Published on: February 01, 2016 Effective Date: February 01, 2016

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