How removal of titanium dioxide from medicinal products would impact the pharmaceutical industry

The use of titanium dioxide (TiO2) in medicinal products is under scrutiny, raising concerns among manufacturers about suitable alternative products.

Widely used in the food, cosmetics, and medicinal industries as an additive, TiO2 has been banned in the food industry in France since January 2020 after a paper was published by ANSES raising concerns about the risks associated with ingesting food additive E171, a mixture of TiO2 particles in dispersed, aggregated, or agglomerated form.

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Mexico accepted as ICH member - PLG LATAM Hub

The Mexican agency, COFEPRIS, received the approval of its membership in November 2021 at the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Products for Human Use, better known as ICH. Prior to this Brazil was the only Latin American country in the ICH, and Mexico is the first Spanish-speaking nation to join.

 

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Five Steps to Navigate the Updated IVDR Transitional Period

The European In Vitro Diagnostic Regulation 2017/746 (IVDR) will become a requirement on May 26, 2022, drastically changing the field for companies selling IVDs within the EU. Devices that do not meet the new requirements will no longer be able to enter the market. However, due to the pandemic and industry setbacks, the European Commission has approved an amendment to the dates of application for products which are already on the market, allowing a progressive roll-out of the IVDR and ensuring the continue supply of these vital products.

 

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Significance of due diligence of MA / Dossier before acquisition

As it becomes more expensive and cumbersome to develop new medicines, the traditional approach of pharmaceutical and biotechnology companies to do everything from R&D through to commercialization is changing. Recent trends show that in-licensing and acquisition of products is fast becoming a favored way to offset the risk of investment in R&D and shortening the time to market the product.

 

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UK Clinical Trials: A New Streamlined Approach

The Clinical Trials Regulation (EU CTR) Regulation EU 536/2014 came into force on January 31, 2022, for all participating European countries. Following the United Kingdom’s (UK) decision to leave the European Union (EU), there are now alternative arrangements for clinical trials conducted in the UK. In this two-part series, we will explore the UK’s new approach, followed by a second article to detail the necessary steps needed for applicants pre-and-post submission.

 

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Information Officer in Germany and Austria

In Germany, pharmaceutical companies, importers, parallel importers or re-importers placing medicinal products that require market authorization or registration onto the market must have an Information Officer – according to Section 74a of the German medicinal products act (Arzneimittelgesetz – AMG). Similarly, in Austria the marketing authorization holder or holder of a registration is obliged to name an Information Officer according to Section 56 of the Austrian medicinal products act.
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April 2022 Monthly Newsletter