The Swiss Mutual Recognition Agreement (MRA) for medical devices between the EU and Switzerland has lapsed on May 26, 2021, and the negotiations between Switzerland and the EU have concluded without any concurrence on Institutional Agreement (InstA).
- March 16, 2022 Medical Devices
- March 8, 2022 Regulatory Software & Services, Health Authority Updates
In addition to completing the requisite xEVMPD data submissions, life sciences organizations will now need to use a web-based application form called the Digital Application Dataset Integration (DADI). The European Medicines Agency (EMA) designed DADI as a long-term replacement for the PDF-based electronic Application Form (eAF), which was incepted to support eCTD submissions.
- March 1, 2022 Pharmaceuticals, Regulatory Labeling
A pharmaceutical label is a monologue between the drug manufacturer and the patients. Miscommunication of any kind can affect the end-user. To protect the interest of the patient population, global Health Authorities (HAs) closely monitor pharmaceutical labels and indications of pre-approval. There are various components to a label and with each additional component, the chances of errors increase gradually.
- February 24, 2022 Cosmetics Regulatory Services, Regulatory Affairs
Hair colorants are classified as cosmetic products by the European Commission (EC) and are regulated under the regulation (EC) No: 1223/2009. Hair colorants contain a mixture of substances called hair dyes that are used to change the color of hair or to restore the original hair color. They are classified into the following three (03) categories based on their color fastness:
- February 23, 2022 Food and Food Supplements
FSSAI published a major update on the Front Pack of Labelling (FOPL) on 22nd February 2022 after a meeting with the stakeholders, to decide the remaining issues related to ‘Front of Pack Labelling’ under the Chairmanship of CEO, FSSAI. The FSSAI commenced the meeting with a presentation on the development journey of FOPL in India and the decisions taken in the last meetings.
- February 22, 2022 Medical Devices
Medical devices need an efficient, effective, and readily available user manual. Over time, paper Instructions for Use (IFU) have been the norm in the medical device industry. However, with the advent of electronic technologies, the paper IFU has been replaced by electronic IFU (eIFU).
- February 22, 2022 Pharmaceuticals, Regulatory Affairs
To enhance the accessibility of innovative medicines for patients in the UK post-Brexit, a new and accelerated approval pathway is known as the Innovative Licensing and Access Pathway (ILAP) was launched in January 2021. Its primary objective was to provide an integrated roadmap for all the stakeholders that enhances the process of product development.
- February 22, 2022 Pharmaceuticals, Regulatory Affairs
Canada ranks ninth in the world in value for generic drugs and has reached $5.8bn in sales as of today in 2022. To make effective, safe, and affordable drugs readily available to patients in the country, Health Canada – Canada’s Health Authority, is taking initiatives to improve the accessibility of generic products.
- February 22, 2022 Pharmaceuticals
While innovators or branded drug products carry additional costs associated with the research and development of the product from the molecule identification stage to post-market authorization, generic drug products are relatively cost-effective. These therapies not only reduce the overall cost of treatment, but also significantly improve patient access to life-saving drug products.
- February 21, 2022 Medical and Scientific Communication, Pharmaceuticals, Health Authority Updates
To educate patients and Health Care Professionals (HCPs) and promote treatment options, the pharmaceutical industry like many other industries dedicates billions of dollars to advertise and promote prescription drugs. The legislative framework of advertising in Australia comes under Section 42BAA of the Therapeutic Good Act 1989.