MHRA releases final consultation response for the Falsified Medicines Directive

A public consultation was launched by the Government in July 2018 regarding actions that need to be taken to ensure that the United Kingdom (UK) meets its obligations to apply the provisions of the Falsified Medicines Directive (FMD). The FMD requires ‘safety features’ to be applied to the packaging of specified medicinal products. The consultation closed on 23rd September 2018, and the final consultation response has been published with the Medicines and Healthcare Products Regulatory Agency’s response to over 50 replies that were received from a variety of stakeholders. Read more “MHRA releases final consultation response for the Falsified Medicines Directive”

Implementing ‘safety features’ under the Falsified Medicines Directive

Falsified medicines present a threat to public health in several ways, such as adverse reactions, interaction with other medicines and loss of faith in healthcare systems. Currently there is no mechanism that allows users to verify where a medicine has come from. The European Union (EU) Falsified Medicines Directive (FMD) aims to prevent falsified medicines from entering the legitimate supply chain and reaching patients. The ‘safety features’ policy requires a unique identifier and tamper-evident features to be added to prescription medicine packs by 9th February 2019.  Read more “Implementing ‘safety features’ under the Falsified Medicines Directive”

TGA Australia to implement process for comparable overseas regulators

Following a 2016 regulation that aimed to improve access to medical products in Australia, the Therapeutic Goods Administration (TGA) has implemented criteria to aid pharmaceutical companies in identifying comparable overseas regulators (COR), including a formal process for work-sharing on drug applications using foreign reports. Read more “TGA Australia to implement process for comparable overseas regulators”

FDA revises draft guidance on metered dose and dry powder inhalers

The United States (US) Food and Drug Administration (FDA) have revised draft guidance on the development and manufacture of inhalation aerosols (also known as metered dose inhalers (MDIs)) and inhalation powders (also known as dry powder inhalers (DPIs)). The guidance describes points to consider in order to ensure product quality and performance for MDIs and DPIs. It states chemistry, manufacturing, and controls (CMC) information recommended for inclusion in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Read more “FDA revises draft guidance on metered dose and dry powder inhalers”