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Smart & Biggar | Canada | 7 Jun 2023
CADTH consultation on time-limited reimbursement initiative and IMC report on what Canada can learn from Europe
The Canadian Agency for Drugs and Technologies in Health has released a consultation document for a proposed process for time-limited reimbursement recommendations. The initiative aims to help ensure timely access to promising new therapies and would better align with conditional regulatory approval. Meanwhile, Innovative Medicines Canada has released a report that outlines various......
Smart & Biggar | Canada | 31 May 2023
Health Canada opens consultation on proposed application of definition of Canadian reference product based on dormant status
A generic drug manufacturer can file an abbreviated new drug submission based on a comparison to a Canadian reference product. Health Canada recently opened for consultation a proposed application of the definition of "Canadian reference product" under C.08.001.1(b) of the Food and Drug Regulations.
Lexology PRO | Indonesia | 30 May 2023
Indonesia fines cooking oil cartel, drops claims against 20 companies
Indonesia’s Competition Commission has fined seven cooking oil producers €4.4 million for colluding to restrict supply, despite a board member's dissenting opinion arguing that 27 accused businesses illegally fixed prices.
Richmond Chambers Immigration Barristers | United Kingdom | 24 May 2023
Fishing Jobs to Be Added to the Shortage Occupation List
The UK’s seafood sector, known for its high-quality exports such as salmon and Cornish sardines, plays a crucial role in the country’s economy. To…
Lexology PRO | Philippines | 22 May 2023
Philippine lawmaker pushes for first criminal sentences in cartel probe
A senior Philippine lawmaker has called on the country’s competition watchdog to impose its first-ever criminal sentences on individuals alleged to have colluded to raise the price of onions.
Lee and Li Attorneys at Law | Taiwan | 22 May 2023
TIPO promulgates draft amendments to patent term extension legislation
The Taiwan Intellectual Property Office (TIPO) recently promulgated draft amendments to the Regulations Governing the Determination of Patent Term Extension. The amendments aim to simplify the examination procedure for patent term extension applications. They remove the requirement for the TIPO to send the clinical trials list or the relevant documents and data submitted by the applicant to......
Lexology PRO | Asia-Pacific, Australia, Canada, etc. | 19 May 2023
Product regulation and liability: key updates and risks (May 2023)
The US FTC issues the largest “Made in USA” false labelling fine, the EC adopts new product safety rules for online sellers, and Australia announces its largest tobacco reforms in a decade – plus other key updates.
Lexology PRO | Belgium | 12 May 2023
Belgium considers first merger block
The Belgian Competition Authority’s investigative arm has called on the agency to stop a national meat processor from acquiring two subsidiaries of a Mexican multinational food company, which would mark the enforcer’s first prohibition since it was formed in 2013.
Lexology PRO | Israel | 10 May 2023
Israel scores €2.1 million settlement over delivery platform exclusivity
Food delivery platform Wolt has settled with Israel’s Competition Authority after admitting to anticompetitively promoting restaurants that exclusively signed onto its service.
Keller and Heckman LLP | USA | 10 May 2023
The Reagan Udall Foundation - A Critical Evaluation of FDA’s Center for Tobacco Products
In July 2022, the Food and Drug Administration (FDA) Commissioner, Dr. Robert Califf, released a public statement saying the agency “has confronted a…
