Robin Ayoub’s Post

Need assistance with #translations for #medicaldevice development, drug authorizations, or post-approval of your medicinal drugs or devices in the EU? Lionbridge's new blog breaks down the EU's #multilingual policy to help you ensure compliance.

Need assistance with #translations for #medicaldevice development, drug authorizations, or post-approval of your medicinal drugs or devices in the EU? Lionbridge's new blog breaks down the EU's #multilingual policy to help you ensure compliance.

Need assistance with #translations for #medicaldevice development, drug authorizations, or post-approval of your medicinal drugs or devices in the EU? Lionbridge's new blog breaks down the EU's #multilingual policy to help you ensure compliance.

Do you need assistance with #translations for #medicaldevice development, drug authorizations, or post-approval of your medicinal drugs or devices in the EU? Lionbridge's new blog breaks down the EU's #multilingual policy to help you ensure compliance.

Controlled drugs may soon be cheaper! It was only yesterday that I was speaking at a seminar and raised the issue of Reg 23 which forms part of our patent linkage system. Under the current system generic drug companies are often faced with patent suits when they apply for registration of their drugs in Singapore. Unlike other countries there is currently no exception to what must be declared during the application process. This has led to patentees commencing legal proceedings to delay market entry of the generic drugs. The proposed changes to Reg 23 seeks to limit the type of patents that needs to be declared such that more generic drugs will be able to enter the market without fear of its drug registration application be scuttled by litigation. This will hopefully havd an impact on the costs of medicine and healthcare in Singapore

In this week's Inadequate Response posting we note that it's not like FDA doesn't clearly explain how all of this is supposed to work. So, why do companies keep making the same mistakes? It's one of life's mysteries. But it wouldn't be if companies would recognize that when there's even a remote possibility that their product might fall under FDA's scope, they should seek expert guidance. #QRxPartners #QRxInforms #FDA #WarningLetter #InadequateResponse #MLV

Transition from ethical drugs to generics after patent expiration, how the FDA or EMA process works for drugs? If anyone has original procedures and protocols as an example, would be appreciated share. What regulatory checkpoints are there to ensure that generics have the same safety and efficacy? Surprisingly, several Gereics drugs are now being identified with widely varying efficacy, which should not be ignored but is a cause for concern when it comes to meeting patients' medical needs. #PK/PD#First Pass-Effect#Drug-Drug interactions#drug-food interactions#Bioequivalance challange#

🖋 It was a light week for FDA Warning Letters, but two were focused on foreign drug manufacturers where the themes were nearly identical; not just between the two, but to many other recent Warning Letters to foreign and domestic drug manufacturers. Here are the high, (or should we say low?) points: 🛑 Failure to test samples of drug components.  🛑 Failure to investigate batch discrepancies.  🛑 Failure to prepare batch records.  🛑 Failure to prevent contamination.  🛑 Failure to ensure data integrity.  Every week it's pretty much the same issues. Maybe the FDA needs to consider providing a kind of FDA 101 guide to manufacturing regulated products. 🤔 Oh wait, they do! 🤓 It starts on their website with a page titled, "I want to manufacture an FDA-regulated product, where do I start?" 👉 https://lnkd.in/gGfRQyKt Or, you could just go to the web page specific to your type of product, devices, drugs, and everything else under the FDA's scope. Given all this free guidance, it would be hard for any manufacturer to claim ignorance. In law, the Latin phrase, "ignorantia juris non excusat" roughly translates to "ignorance is no excuse for the law".  As we advise here every week, don't be a hobbyist in the medical technology space. That leads to ignorance. As the FDA often advises in Warning Letters, by which time it's too late, engage qualified consultants to get everything right.  Otherwise, be ready to become an example of what not to do. As always, QRx Partners are here to help. Contact us to start the conversation. We like to think we're a much more fun conversation than with the FDA. 🤝 #QRxPartners #QRxInforms #mlv #InadequateResponse #fda #FDAcompliance #regulatory #RegulatoryCompliance #FDAguidance #FDAguidance #HereForYou

Regulation Amendments for Reporting Serious Adverse Reactions of Medicaments The regulations for reporting severe adverse reactions of medicaments are established according to Article 45-1 of the Pharmaceutical Affairs Act and have been in effect for 20 years. The Ministry of Health and Welfare now references requirements and standards from the United States, European Union, Japan, and other countries, and aligns with the implementation of the Medical Devices Management Act. As the original regulations in the Pharmaceutical Affairs Act no longer apply to medical devices, the regulations and their title have been revised to 'Regulations for Reporting Severe Adverse Reactions of Medicaments'. These amendments will comprehensively take effect on January 1, 2025. The following are the key points of amendments to the regulations. TALENT's insights in full. https://lnkd.in/gJezwHNz

Navigating EU Compliance for Medical Devices and Medicinal Products? We’ve Got You Covered! Struggling with translations for medicaldevice development, drug authorizations, or post-approval processes in the EU? Compliance with the EU’s multilingual policy can be challenging, but it’s essential for success. Lionbridge’s latest blog simplifies this complex topic and offers practical insights to help you stay compliant. 🚀 Learn how to manage translations effectively and ensure your products meet EU requirements. #LifeSciences #Localization #EUCompliance