Regulatory Surveillance Summary | January, 2020

By Laurel Hacche and Debra Cortner, SQA Associates

Health Canada Regulations/Guidances

Regulation of Vaping Products in Canada, December 2019

On 19 December 2019, Health Canada announced the final “Vaping Products Labelling and Packaging Regulations,” creating new labeling and packaging requirements for vaping products to increase awareness of the health hazards of using vaping products, help prevent the public from being misled about those hazards, and help protect the health and safety of Canadians, especially young children, by reducing the risk that they will ingest vaping substances containing toxic concentrations of nicotine. Health Canada consulted Canadians on the “Vaping Products Labelling and Packaging Regulations” from June to September 2019. The Department considered all feedback in the development of the final regulations. The regulations require that vaping substances display important health and safety information. Vaping products containing nicotine must display a standardized nicotine concentration statement and a health warning about the addictiveness of nicotine. In addition, vaping products containing nicotine must be packaged in child-resistant containers and display a toxicity warning and first-aid treatment statement. A list of ingredients must be displayed on all vaping substances, regardless of nicotine content. These regulations will come into force on 01 July 2020 with one exception. The requirement for refillable vaping devices and their parts to be child-resistant will come into force on 01 January 2021.

Mandatory Adverse Event Reporting for Canadian Hospitals, December 2019

On 16 December 2019, new mandatory reporting requirements for hospitals came into force. These regulations help to improve the reporting of serious adverse drug reactions and medical device incidents. They are a key part of implementing the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law). Improved reporting will help Health Canada better monitor the safety and effectiveness of products once they are on the Canadian market. Under the regulations, hospitals are required to report to Health Canada all serious adverse drug reactions and medical device incidents within 30 days of being documented at the hospital.

Health Canada Recalls, November 2019

Certain lots of PregVit and PregVit folic 5 vitamin-mineral supplements have been recalled because blister packages may contain all pink (morning) tablets instead of the correct combination of pink (morning) and blue (evening) tablets. Duchesnay Inc. estimates that the issue affects a very small number of products in certain lots and not all products. There are no quality, safety, or effectiveness concerns with the tablets themselves, but there is the potential that patients may not take the proper combination of pink and blue tablets if they have received products impacted by the packaging error. The pink and the blue tablets do not contain the same active ingredients. Women taking all pink tablets will not receive the intended vitamin and mineral supplements. In particular, the pink tablets do not contain folic acid, which is important for the healthy growth of an unborn baby and helps to reduce some types of birth defects called neural tube defects. Properly packaged products should contain two blister packs, with each blister pack containing 15 pink tablets and 15 blue tablets. The company received a complaint of a product containing a blister pack that contained all pink tablets and no blue tablets.

Medicines & Healthcare Products Regulatory Agency (MHRA)

MHRA and the Bill & Melinda Gates Foundation to Look at the Safer, Effective use of Medicines During Pregnancy, 17 September 2019

In advance of World Patient Safety Day (17 September), MHRA specialists, as part of a broader program of work, have begun developing groundbreaking research to support the safer use of medicine during pregnancy. A $360,000 grant over two years from the Bill & Melinda Gates Foundation (approximately £292,000) will support the MHRA’s research to help predict the need for adjusting a medicine’s dose during different trimesters of pregnancy. This will ensure effective use, which is vital for the health of the mother and baby. Worldwide, data in this area remain limited, and new insights could have a positive impact on the health of pregnant women around the world. These insights would also give obstetricians further clarity on the optimal dose of a medicine when treating pregnant patients for whom the use of medicine is necessary.

International Conference on Harmonization (ICH)

ICH Q12 and Annexes reach Step 4 of the ICH Process, 04 December 2019

The ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and its Annexes reached Step 4 of the ICH Process at the ICH meeting in Singapore on 21 November 2019. The ICH Q12 Guideline is intended to complement the existing ICH Q8 to Q11 Guidelines, and it provides a framework to facilitate the management of post-approval Chemistry, Manufacturing, and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. The adoption of this new ICH Guideline will promote innovation and continual improvement in the biopharmaceutical sector, as well as strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. It will also allow regulators (assessors and inspectors) to better understand firms’ Pharmaceutical Quality Systems (PQSs) for the management of post-approval CMC changes.

The European Federation for Cosmetic Ingredients (EFfCI)

No updates for The European Federation for Cosmetic Ingredients were noted for January 2020.

European Medicines Agency (EMA)

EMA Brexit-Related Guidance for Companies, January 2020

The European Medicines Agency (EMA) and the European Commission are providing guidance to pharmaceutical companies responsible for both human and veterinary medicines in preparation for the United Kingdom’s (UK) withdrawal from the European Union (EU), a process known as “Brexit.” The current expected date of exit is 31 January 2020, unless an additional extension is granted. Marketing authorization holders were given a deadline of 01 January 2020 to ensure that all batch-testing facilities are fully transferred to the EU27/EEA and the necessary regulatory submissions are completed.

Pilot Program for Inspection of Sterile Medicines, January 2020

EMA and its European and international partners are launching a pilot program to increase their cooperation in the inspection of manufacturers of sterile medicines for human use. This collaboration will allow EMA, EU national authorities (France and the United Kingdom), the United States Food and Drug Administration (FDA), Australia’s Therapeutic Goods Administration (TGA), Health Canada, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the World Health Organization (WHO) to share information on Good Manufacturing Practice (GMP) inspections of manufacturers of sterile medicines who are located outside the participating countries and to plan joint inspections for manufacturing sites of common interest.

EMA Update on EU-USE Mutual Recognition Agreement on Marketing Authorization Applications and Relevant Variations, 17 December 2019

The European Medicines Agency has published a document clarifying details of the Mutual Recognition Agreement. For example, as the US FDA does not issue GMP Certificates, applicants should submit proof of GMP compliance for US manufacturing sites that have been previously inspected by the US FDA. Documentation includes the 90-day facility classification decisional letter issued by the FDA, a screenshot from the FDA Inspectional Classification Database, the most recent relevant FDA Establishment Classification Report, and where applicable, the export certificate. The documents should be submitted in Annex 5.9 of the Application Form. It is recommended that the applicant discuss with the regulatory authorities the possibility of inspections when planning to file an EU marketing authorization or variant.

EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use – Chapters and Annexes

No updates for EudraLex were noted for January 2020.

Medical Device Coordination Group

Medical Device Coordination Group Emergo, 07 January 2020

The Medical Device Coordination Group (MDCG) published new guidelines on 06 January 2020 to help manufacturers fulfill relevant cybersecurity requirements in Annex 1 of the Medical Device Regulation and In-vitro Diagnostic Medical Devices Regulation (IVDR). The guidance lays down certain new essential safety requirements for all medical devices that incorporate electronic programmable systems and software that are medical devices in themselves. Manufacturers are required to develop their devices in accordance with the state of the art. Both premarket and post-market cybersecurity requirements are included.

Chinese Cosmetic Regulations

The Center for Food and Drug Inspection of the National Medical Products Administration has issued a document draft for comments formulated to regulate the overseas inspection of cosmetics. The document shall apply to the inspection of overseas development and production-related processes of cosmetics that have been marketed or are to be marketed within the territory of the People’s Republic of China. The inspections are to be carried out by the National Medical Products Administration (NMPA). The NMPA determines the annual inspection plan through risk assessment and random spot checks. Potential risks can be identified through the review and approval process, inspection results that do not conform to provisions, adverse reaction monitoring, complaints, or clues suggesting illegal activity. The inspection team is generally composed of three to five inspectors who will inspect according to a pre-determined plan. The document provides details of the reporting and response process.