CANADA (HEALTH CANADA)

Transcription

1 1 GMP GAZETTE TM March 2015 HPFBI CANADA (HEALTH CANADA) Notice, Re: Regulatory Decision Summaries and Submissions Under Review Who s affected? Manufacturers of prescription drugs (pharmaceuticals and biologics) and medical devices, along with individuals seeking information about Health Canada s decisions to authorize these products for sale in Canada The Health Products and Food Branch (HPFB) is phasing in the online publication of positive and negative regulatory decisions, along with a list of submissions under review starting on April 1, The goal of this initiative is to enhance transparency of the regulatory review process. The notice will apply to prescription drugs (pharmaceuticals and biologics) and medical devices, only in the initial phase. Initiatives related to the communication of Health Canada s rationale for authorizing various consumer health products, such as non prescription drugs and natural health products, will be developed in conjunction with the new framework. Health Canada will use a phased approach on the Canada.ca website, of new drug submissions (NDS) for new active substances (NAS), for pharmaceuticals and biologics that are accepted into review on or after April 1, A list of the submissions that includes the medicinal ingredient(s) and their therapeutic class will be posted. The list of submissions under review will also be searchable. In 2016, the list will be expanded to include all NDSs and Supplemental New Drug Submissions (SNDS) for new indications that are accepted into review on or after April 1, For more information about the Regulatory Transparency and Openness initiatives at Health Canada, refer to the following web link: accueil/rto tor/indexeng.php?hc_source=regulatory_transparency_openness_14&medium=banner_link&content=&campaign=hpfeaturebox

2 2 What s the impact? Canadians will be able to easily access information about Health Canada s decisions to authorize prescription drugs and medical devices. Posting date: March 13, 2015 NNHPD NHPs Good Label and Package Practices Guide - Draft Guidance Document for Industry Who s affected? This guide focuses on the inner and outer labels and package across the range of health products for human use: prescription and non prescription pharmaceuticals, biologics, radiopharmaceuticals and natural health products. Note that while Natural Health Products (NHP) are not covered under the PLL regulations. The guide offers guidance to NHP sponsors as best practices. This guide presents a foundation of design principles for labelling prescription and non prescription pharmaceuticals, biologics, and natural health products (NHPs) intended for human use. NHPs are not covered by the PLL regulatory amendments; however, the guide will provide guidance to NHP sponsors as best practices. What s the impact? Through the Plain Language Labelling Initiative, new regulations amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) have been introduced with the intention of improving the safe use of drugs by making drug labels and packages easier to read and understand. These amendments include a requirement for a standard table format for outer labels of over the counter (OTC) drugs and submission of label and package mock ups. The content presented in this guide will provide information with respect to meeting these two new requirements. Developed in collaboration with the Institute for Safe Medication Practices Canada (ISMP Canada), the objective of the Good Label and Package Practices Guide is to provide sponsors with direction for designing safe and clear labels and packages. The information provided in this guide will aid sponsors in the organization of information required by the Food and Drug Regulations and Natural Health Products Regulations. It will also provide additional recommendations to support the design and development of labels and packages that are clear, effective and support proper identification of the product to minimize the risk of errors causing harm.

3 3 Please see the online version for reference documents. Posting date: This consultation is open from March 3, 2015 to May 4, DISINFECTANTS No updates. NON PRESCRIPTION DRUGS Good Label and Package Practices Guide - Draft Guidance Document for Industry Who s affected? This guide focuses on the inner and outer labels and package across the range of health products for human use: prescription and non prescription pharmaceuticals, biologics, radiopharmaceuticals and natural health products. Note that while Natural Health Products (NHP) are not covered under the PLL regulations. The guide offers guidance to NHP sponsors as best practices. This guide presents a foundation of design principles for labelling prescription and non prescription pharmaceuticals, biologics, and natural health products (NHPs) intended for human use. NHPs are not covered by the PLL regulatory amendments; however, the guide will provide guidance to NHP sponsors as best practices. What s the impact? Through the Plain Language Labelling Initiative, new regulations amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) have been introduced with the intention of improving the safe use of drugs by making drug labels and packages easier to read and understand. These amendments include a requirement for a standard table format for outer labels of over the counter (OTC) drugs and submission of label and package mock ups. The content presented in this guide will provide information with respect to meeting these two new requirements. Developed in collaboration with the Institute for Safe Medication Practices Canada (ISMP Canada), the objective of the Good Label and Package Practices Guide is to provide sponsors with direction for designing safe and clear labels and packages. The information provided in this guide will aid sponsors in the organization of information required by the Food and Drug Regulations and Natural Health Products Regulations. It will also provide

4 4 additional recommendations to support the design and development of labels and packages that are clear, effective and support proper identification of the product to minimize the risk of errors causing harm. Please see the online version for reference documents. Posting date: This consultation is open from March 3, 2015 to May 4, TPD COSMETICS No Updates DRUGS Notice: Therapeutic Products with Paediatric labelling Who s affected? Health care professionals, pharmacist and Canadian consumers Health Canada has taken an initiative to publish a report about therapeutic products that have paediatric information available in their labelling on their website. Children ages 0 18 years have unique health and safety needs, and respond differently to health products than the general population. However, because it is often difficult to obtain scientific data on children, many health products are not formulated specifically for use by this population, and may not have sufficient information in their labelling to guide or support their use. In an effort to bridge this knowledge gap and identify those drug products with data available for the paediatric population, Health Canada is publishing an administrative list of all marketed therapeutic products that have paediatric information related to safety and efficacy available in their labelling.

5 5 What s the impact? Health care professionals will be able to easily check approved drugs with paediatric indications. Posting Date: February 12, 2015 Good Label and Package Practices Guide - Draft Guidance Document for Industry Who s affected? This guide focuses on the inner and outer labels and package across the range of health products for human use: prescription and non prescription pharmaceuticals, biologics, radiopharmaceuticals and natural health products. Note that while Natural Health Products (NHP) are not covered under the PLL regulations. The guide offers guidance to NHP sponsors as best practices. This guide presents a foundation of design principles for labelling prescription and non prescription pharmaceuticals, biologics, and natural health products (NHPs) intended for human use. NHPs are not covered by the PLL regulatory amendments; however, the guide will provide guidance to NHP sponsors as best practices. What s the impact? Through the Plain Language Labelling Initiative, new regulations amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) have been introduced with the intention of improving the safe use of drugs by making drug labels and packages easier to read and understand. These amendments include a requirement for a standard table format for outer labels of over the counter (OTC) drugs and submission of label and package mock ups. The content presented in this guide will provide information with respect to meeting these two new requirements. Developed in collaboration with the Institute for Safe Medication Practices Canada (ISMP Canada), the objective of the Good Label and Package Practices Guide is to provide sponsors with direction for designing safe and clear labels and packages. The information provided in this guide will aid sponsors in the organization of information required by the Food and Drug Regulations and Natural Health Products Regulations. It will also provide additional recommendations to support the design and development of labels and packages that are clear, effective and support proper identification of the product to minimize the risk of errors causing harm. Please see the online version for reference documents.

6 6 Posting date: This consultation is open from March 3, 2015 to May 4, The Drug and Health Product Register Who s affected? Consumers, health care providers, professionals delivering health care services and researchers who are who are seeking information about Canadian drug products Health Canada has announced the Drug and Health Product Register (DHPR) which is a pilot project. Individuals can now search for consumer information about drug product use, safety and common/reported side effects in the DHPR by searching for the: Brand Name Active Ingredient; or Drug Identification Number (DIN) Currently, the DHPR only provides the top 100 prescribed brand name and generic drug products, which have been selected based on the top Canadian sales for An additional 250 products are included which consist largely of generic drugs, but do include some brand name products that have the same active ingredient(s) as the top 100 prescribed drug products. Additional information about the DHPR is available at the following web link: rps.hres.ca/hpr rps/templates/about propos eng.html What s the impact? Consumers can easily access information pertaining to the safety of the drug products they are using and learn how to use health products more effectively. Health care professionals and researchers can easily access regulatory information and data for Canadian health products. Posting date: November 21, 2014 MEDICAL DEVICES

7 7 No Updates CDER USA (FDA) DRUGS Draft Guidance for Industry, Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act Who s affected? Firms that have registered with the FDA under section 503B of the FD&C Act as human drug compounding outsourcing facilities This draft guidance: Explains FDA s current thinking on adverse event reporting for outsourcing facilities o Under section 503B(b)(5) of 22 the FD&C Act, an outsourcing facility must submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section of title 21, Code of Federal Regulations (or any successor regulations). o Failure to report adverse events by an entity that is registered in accordance with section 503B(b) is a prohibited act under section 301(ccc)(3) of the FD&C Act. Violations relating to this provision are subject to regulatory and enforcement action. What s the impact? For comment purposes only. Comments must be submitted either electronically or in writing to the FDA by May 20, 2015 to ensure the Agency considers them before beginning on the final version. Issued date: February 13, 2015

8 8 Draft Guidance for Industry, Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act Who s affected? Entities trying to decide whether to register with the FDA as an outsourcing facility This draft guidance: Answers questions about whether entities engaged in various types of activities (e.g., a facility that is compounding only non sterile drugs or only repackaging biological products) should register as an outsourcing facility Provides potential registrants additional information about the regulatory impact of registering as an outsourcing facility What s the impact? For comment purposes only. Comments must be submitted either electronically or in writing to the FDA by May 20, 2015 to ensure the Agency considers them before beginning on the final version. Issued date: February 13, 2015 CBER VACCINES & BIOLOGICS Draft Guidance for Industry, Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271 Who s affected? Manufacturers of human cells, tissues, and cellular and tissue based products (HCT/Ps) This draft guidance: Provides recommendations for complying with the requirements under 21 CFR Part 1271 for investigating and reporting adverse reactions involving communicable disease in recipients of HCT/Ps that are regulated solely under section 361 of the Public Health Service Act and 21 CFR Part 1271 Provides updated information specific to reporting adverse reactions related to HCT/Ps to supplement the general instructions accompanying the MedWatch mandatory reporting form, Form FDA 3500A

9 9 What s the impact? For comment purposes only. Comments must be submitted either electronically or in writing to the FDA by April 21, 2015 to ensure the Agency considers them before beginning on the final version. Issued date: February 20, 2015 CFSAN COSMETICS Notice, Microbiological Safety and Cosmetics Who s affected? Cosmetic manufacturers, packagers and distributors FDA is looking closely at the microbiological safety of cosmetics, as follows: What the Law Says About Cosmetic Safety How Microorganisms Get Into Cosmetics Questions FDA Is Asking, and Why How Consumers Can Help Protect Against Microbial Contamination How to Report a Problem FDA Resources on Cosmetics and Microbiological Safety Related Resources What s the impact? Cosmetic firms need to be aware of FDA s close scrutiny of the microbiological safety of their product Posting date: February 2015 DIETARY SUPPLEMENTS

10 10 No updates CDRH MEDICAL DEVICES Guidance for Industry & FDA Staff, Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Who s affected? Manufacturers and distributors of these types of devices This guidance: Informs stakeholders that the Agency does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices due to the low risk they pose to patients and the importance they play in advancing digital health 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: February 9, 2015 Guidance for Industry & FDA Staff, Safety Considerations to Mitigate the Risks of Misconnections with Small bore Connectors Intended for Enteral Applications Who s affected? Manufacturers of devices that contain small bore connectors designed for enteral feeding, and companies preparing premarket notification submissions [510(k)s] for these devices This guidance: Recommends that manufacturers design and test enteral connectors based upon specified AAMI standards and test methods to ensure that each

11 11 proposed enteral connector is physically incompatible with non enteral devices o Unintended connections between devices that have different intended uses has resulted in serious and sometimes fatal consequences to patients. Notifies manufacturers submitting 510(k)s or modifying a device already cleared for enteral connectors that color coding, labeling, and tagging attached to the device, by themselves, are no longer sufficient to satisfy safety concerns regarding misconnection hazards associated with connectors Recommends that when submitting a 510(k) or modifying an existing product already cleared via 510(k), a manufacturer should perform a risk assessment to assess the risks of the proposed enteral connector misconnecting to non enteral devices 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: February 11, 2015 USP (GENERAL CHAPTERS) Notice of Intent to Revise: General Chapter <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 Dibuthyldithiocarbamate (ZDBC) from Hatano Research Institute was identified and determined to be suitable as a Positive Control. Posting Date: January 30, 2015; updated February 27, 2015 Updated to indicate that the proposed IRA will be published in Pharmacopeial Forum (PF) 41(3) [May Jun. 2015]. The previous posting had indicated that it would be posted in PF 40(2) [Mar. Apr. 2015]. Targeted Official Date: Interim Revision Announcement; November 1, 2015