REGULATOR PIPELINE

Stay current with new announcements and recent updates from the regulators at Health Canada!

Guidance on Drug Establishment Licences (GUI-0002)

Drug Establishment Licence Application: Forms & Instructions (FRM-0033)

DEL Bulletin LEPP No. 116 Canada and European Union – Recognition of Good Manufacturing Practices Extra-Jurisdictional Inspection Outcomes

Drug good manufacturing practices (GMP) and drug establishment licence (DEL) enforcement policy (POL-0004)

Good manufacturing practices inspection policy for drug establishments (POL-0011)

Health Canada to monitor the inclusion of disaggregated data in clinical evidence: Notice to stakeholders

Forward Regulatory Plan 2022-2024: Regulations Amending the Food and Drug Regulations, Natural Health Products Regulations and the Medical Devices Regulations (Modernization of the Regulation of Clinical Trials)

Forward Regulatory Plan 2022-2024: Advanced Therapeutic Products Pathway for Adaptive Machine Learning-enabled Medical Devices

Forward Regulatory Plan 2022-2024: Regulations amending the Food and Drug Regulations (Improving Access to Generic Drugs)

RECENTLY UPDATED GUIDANCES

GUI-0001 (July 2020) Good manufacturing Practices Guide for Drug Products

GUI-0069 (August 2020) Guidelines for Environmental Control of Drugs During Storage and Transportation

GUI-0117_(Dec 21, 2020) Importing and Exporting Health Products for Commercial Use

GUI-0074 (May 3, 2021) Process Validation: Terminal Sterilization process for drugs

GUI-0028 (June 29, 2021) Cleaning Validation Guide

GUI-0029 (June 29, 2021) Guide to Validation – drugs and supporting activities

DEL Bulletin LEPP No. 118 (August 2021) – Notice of Publication – GUI-0050 Avis de publication – GUI-0050

COVID-19 UPDATES
FROM PSG

A MESSAGE TO OUR MEMBERS, SPONSORS & PARTNERS

At PSG, we are closely following the developments of the COVID-19 pandemic. At this time, we would like to reassure our members that it remains our priority to ensure that our events offer a safe and healthy learning environment to all involved. As a result of our commitment to our members, the PSG will be deferring all In-Class Training Sessions until further notice. If you are registered for an event durning this time, you will be notified personally about these changes by our office.

We are working hard with our partners to develop shared solutions. As much as possible, we will offer online training and events to ensure that our members can receive our services remotely. We will continue to monitor and reassess this situation and will provide updates as they become available.

We thank you for your ongoing support and wish you all well in health during this time. If you have any questions or concerns, please email info@psg.ca.

REGULATOR PIPELINE

Stay current with new announcements and recent updates from the regulators at Health Canada!

RECENTLY UPDATED GUIDANCES

COVID-19 UPDATES FROM PSG

COVID-19 UPDATES
FROM PSG