Pharmore Legal and Compliance’s Post

The Commission welcomes the adoption by the European Parliament today of measures, proposed by the Commission in January 2024, to improve the availability of in vitro diagnostics (IVDs) for patients and healthcare providers. These measures include granting more time to companies to transition to the new EU rules on IVDs, introducing a new obligation on manufacturers to inform national authorities and the health sector in case of disruption of supply of certain medical devices and allowing for the gradual roll-out of the European Database on Medical Devices - Eudamed. The measures give more time to consider possible actions to safeguard patient care in instances where certain devices are discontinued and increase transparency regarding medical devices on the market.

Sweden moves forward with their reverse auction scheme for BioCCS. Great to see more and more European countries implementing different sorts of deployment incentives for CDR. Equally interesting will be to scrutinize the quality of the projects supported by this auction scheme and the price discovery it will allow. https://lnkd.in/dgzTYFP2

Shocking. Link is in the video to official paper.

A key aspect of effective international patent prosecution is understanding nuanced distinctions between important patent jurisdictions. Daniela Fasoli (Simoes Intellectual Property) and I have published an article in Life Sciences IP Review on key similarities/distinctions in Brazil and the U.S., particularly in the life sciences arena. https://lnkd.in/gmrcXGPi

1️⃣✔️ 2️⃣✔️ 3️⃣✔️ We’ve got one last one for you today on the PDA Letter Annex 1 series: Has the Annex 1 2022 revision been a success? An all the more interesting question for us to ask given #Canada’s presently going through its adoption phase. Read on to get the breakdown! https://lnkd.in/ecr55CGP #LifeScience #SciencesDeLaVie #Pharmaceuticals #Biopharma #Annex1 PDA - Parenteral Drug Association

My latest article.

Why is this mother Crying? https://lnkd.in/gAHrre8 ITS BACK ON THE MARKET A too toxic x-ray contrast medium (dye) that was taken off the market in 1992 because of this and caused horrendous injury and unrelenting chronic pain and death in 107 Countries Made from Hydrochloric Acid, Sulphuric Acid, Benzene, a solvent and ethanol and 30.6% of iodine developed by Eastman Kodak and admitted at a Court Deposition by its Manufacturer Alcon. https://lnkd.in/gZTct9Vz I was also injected but survived. Also President John F Kennedy UK Government speaks out. https://lnkd.in/gTwPz9w8 NOW MADE IN CHINA. All can be supported by historical documents and unearthed internal correspondence by those involved. Where are the news media??? Remember it’s BACK on the Market out of China, bypassing the regulators classified as a powder not a drug sent directly to end users.

My latest article.

General Medical Industrial Group Signed Strategic Cooperationwith Chinese Biggest government owned company SPEC. Now we own strong construction team and financial/money support If you have good relationship with your government? If you have channel to win project from your government? Let's work and win-win together #Partnership #StrategicCooperation #GeneralMedical #SPEC #Construction #FinancialSupport #GovernmentProjects

My latest article.