article thumbnail

EMA publishes updated Q&A for ICH M10

European Pharmaceutical Review

These concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinal products. The draft ICH M10 guideline was published for comments in 2019. The post EMA publishes updated Q&A for ICH M10 appeared first on European Pharmaceutical Review.

article thumbnail

Securing every dose with an edible security technology for safe medicines

European Pharmaceutical Review

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. 1 Simply, pharmaceutical products are the most vulnerable to counterfeiting. 1 Simply, pharmaceutical products are the most vulnerable to counterfeiting.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

The imperative of fridge-free vaccines

European Pharmaceutical Review

25 In 2021 an estimated 25 million children under the age of one year did not receive basic vaccines, and the number of completely unvaccinated children increased by five million since 2019. 2019; 9:11409. Injection Safety Fact Sheet. 5 million lives annually for decades. Novel functions and applications of trehalose.

article thumbnail

Everything You Need to Know About Market Access in China

PM360

Given China’s status as the world’s second most populous nation and an economic powerhouse, it represents both a monumental market opportunity and a dynamic arena of challenges for pharmaceutical products. Regulatory body – NMPA : all pharmaceutical products sold in the Chinese market need to be granted market authorization by NMPA.

Marketing 105
article thumbnail

LAMP assays to enable rapid and sensitive detection of BCC

European Pharmaceutical Review

According to researchers, a ribB -based colorimetric loop-mediated isothermal amplification (LAMP) assay could become a fast and easy-to-perform detection method for testing non-sterile pharmaceuticals for BCC. Burkholderia species are one of the primary causes of non-sterile pharmaceutical product recalls and accounted for 45.3

article thumbnail

Sustainable pharma packaging: breaking down the barriers to adoption

European Pharmaceutical Review

However, for the pharmaceutical industry, the challenge is not as simple as just switching materials. An industry that is among the world’s biggest polluters is caught in a balancing act between satisfying the health and safety demands of industry regulators and meeting the needs of modern eco-conscious consumers.

Pharma 84
article thumbnail

Tackling fake pharmaceuticals: an industry united against counterfeit products

European Pharmaceutical Review

For pharmaceutical manufacturers, the primary solution has long been to build anti-counterfeiting technology directly into medical packaging – providing a convenient method for tracking products across supply chains as well as visual authenticity for the consumer. Supply-chain visibility. A united front.