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South African Health Products Regulatory Authority Board has been appointed

The Minister of Health has appointed the board members of the newly established South African Health Products Regulatory Authority (SAHPRA). This health agency is the successor to the Medicines Control Council (MCC) which for decades has been the only medicines regulator in South Africa. A well-resourced and streamlined regulator is seen as the first step … Continue reading

Ontario introduces legislation requiring disclosure of payments to physicians

Following a consultation, legislation was introduced in the Ontario Legislature on September 27, 2017 that will require pharmaceutical and medical device manufacturers to disclose financial relationships to healthcare professionals and organizations. The Health Sector Payment Transparency Act is one of several acts introduced by Bill 160. It will require manufacturers, wholesalers, marketing firms, and others … Continue reading

Ontario announces sales of recreational cannabis framework

On September 8th, Ontario announced its much-anticipated framework for the distribution and sale of recreational cannabis. This announcement makes Ontario the first province to outline a comprehensive response to the Federal government’s plan to legalize cannabis by July 2018. Ontario’s proposed approach largely mirrors the Province’s approach to the sale of alcohol and tobacco. Recreational … Continue reading

Australia: Improvements for GMP clearance

Australia’s therapeutic goods regulator, the Therapeutic Goods Administration (TGA) has announced that it is planning improvements around Good Manufacturing Practice (GMP) clearance. As part of this, the TGA will be publishing an updated revision of the GMP clearance guidance document, and redesigning the current GMP Clearance application e-forms. GMP clearance is required for all medicines … Continue reading

US telemedicine industry players are pursuing opportunities abroad

Telemedicine has been rapidly expanding in the United States. Indeed, Texas recently passed legislation that gives Texas telemedicine providers more flexibility, including the ability to establish a physician-patient relationship in connection with telemedicine services without requiring an in-person visit. Business entrepreneurs are finding ways to expand telemedicine opportunities internationally as well. NBC News recently published … Continue reading

Ontario legislature clarifies mandatory privacy breach reporting requirements under the Ontario Personal Health Information Protection Act

In Ontario, the Personal Health Information Protection Act (PHIPA)[1] governs the collection, use and disclosure of personal health information within the health sector. The term “personal health information” is broadly defined in PHIPA and includes identifying information which is not strictly personal health information but is contained in a record containing personal health information. Health … Continue reading

The European Court of Justice lowers causation standard of proof, finds vaccine could cause multiple sclerosis absent hard science

In an opinion that could significantly lower the threshold for proof of general causation in product liability lawsuits if adopted elsewhere, on June 21, 2017, the European Court of Justice held that a court could find a vaccine “defective” and thus the cause of a disease, even where no medical research supported such a causal … Continue reading

Health Canada releases Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products

Health Canada recently released the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health as part of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) – more commonly known as the “Plain Language Labelling Regulations.” As of June 13, 2017, the Plain … Continue reading

Impact of Brexit on marketing authorisation holders – new EMA and CMDh guidance

The European Commission and European Medicines Agency (EMA) have published a Q&A document (the EMA Q&A) concerning the legal consequences for marketing authorisation holders (MAHs) of centrally authorised medicines if the UK becomes a ‘third country’ after Brexit. The EMA Q&A provides further detail following the European Commission and EMA notice of 2 May 2017. … Continue reading

FDA / EMA parallel scientific advice principles published

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) recently released an updated “General Principles” statement regarding the agencies’ parallel scientific advice (PSA) program for human medical products. The PSA program provides scientific advice and protocol assistance in parallel to sponsors. “Sponsor” refers to: in the US, the sponsor of an Investigational … Continue reading

European Union’s new medical device regulations come into force

Today, 25 May 2017, two new Regulations come into force in the European Union: the Medical Device Regulation (MDR) which replaces two EU Directives on general medical devices and active implantable medical devices; and the In Vitro Diagnostic Medical Devices Regulation (IVD MDR) which replaces the EU Directive on IVD medical devices. Now begins a … Continue reading

Mandatory kilojoule labeling – Victoria, Australia

The Victorian Government has introduced the requirement that all major Victorian food outlets and supermarket chains must display kilojoule contents on their menus. The Food (Kilojoule Labelling Scheme and Other Matters) Amendment Act 2016 will, from May 2018, require large chain food businesses and large chain supermarkets to display: the average kilojoule content of standardised, … Continue reading

Medical assistance in dying in Canada: one year later

Since the Canadian federal government introduced legislation governing medical assistance in dying (“MAiD”), the provinces and territories, which are responsible for the delivery of health care services in Canada, have adopted a variety of processes and procedures to deal with requests for MAiD. However, some questions and issues which have arisen with the legalization of … Continue reading

Canadian Government looks to Supreme Court of Canada for opinion on the constitutionality of the Genetic Non-Discrimination Act

In March 2017, Parliament gave third reading to Bill S-201, also known as the Genetic Non-Discrimination Act. The Genetic Non-Discrimination Act was introduced as a Senate bill by now-retired Liberal Senator James Cowan in December 2015 to ensure that fear of genetic discrimination did not prevent Canadians from deciding to proceed with genetic testing which … Continue reading

Court upholds Health Canada decision requiring additional information ‎on certain Apotex drugs manufactured in India

The Federal Court dismissed Apotex’s application for judicial review of the Minister of Health’s decision to require additional information from Apotex as part of its submissions for certain drugs manufactured in India by Apotex affiliates. Read the full update here.… Continue reading

NICE to fast-track more medicine approvals but wider changes do not impress industry

The National Institute for Health and Care Excellence (NICE) produces guidance in a number of forms including technology appraisals. Technology appraisals are recommendations on the use of medicines and treatments within NHS England. The recommendations are based on a review of clinical and economic evidence. NHS England is legally obliged to fund medicines recommended by … Continue reading

European and US regulators’ agreement on mutual recognition of inspections of medicines manufacturers

In the European Union (EU), inspections of medicines manufacturing sites are carried out by national competent authorities from EU Member States. Each year, EU competent authorities and the US Food and Drug Administration inspect many manufacturing sites in the EU, US and elsewhere in the world, to ensure compliance with Good Manufacturing Practice (GMP). EU … Continue reading

The UK Government’s Brexit White Paper and its impact on the life sciences sector

On February 2, 2017, the Government published a White Paper on its plan for exiting and achieving a new partnership with the EU. The White Paper expands upon Prime Minister Theresa May’s speech on January 17, 2017. We have previously written about the speech and earlier developments (The UK government’s Brexit plan and its implications for Life Sciences). See … Continue reading

Global health trends impacting the regulation of food and beverage labels

As global rates of obesity and related diseases continue to rise, consumers around the world are becoming more health conscious, and are expecting their food products to reflect their desire for healthier options. A recent Nielsen Global Health and Wellness Survey found that, of the 30 000 people across 60 countries surveyed, 49% consider themselves … Continue reading

Health Canada releases draft guidance documents for consultation related to good manufacturing practices and drug establishment licensing

On January 18, 2017, Health Canada released five draft guidance documents for consultation relating to good manufacturing practices and drug establishment licensing. The consultation period is open until April 18, 2017. Read the full update in Norton Rose Fulbright’s Pharma in brief – Canada.… Continue reading
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