Biologicals are booming as therapy and have significantly become an established treatment option to provide ailment to niche disease segments which seemed impossible earlier. COVID-19 pandemic has made researchers keen to develop biosimilar and interchangeable products for the patient population at an affordable price.
- November 3, 2021 Biologicals, Regulatory Affairs
- October 26, 2021 Pharmaceuticals, Regulatory Affairs, Publishing & Submissions
China has established its position as a manufacturing hub for pharmaceuticals. Innovation in manufacturing techniques has encouraged China to explore the scope of research and development for medicinal preparations. The National Medical Products Association (NMPA) looks after the safety of drugs, medical devices, and biologics along with their regulation by undertaking their standards’ management.
- October 12, 2021 Cosmetics Regulatory Services, Regulatory Affairs
The use of red/brown- and green-colored dots to classify vegetarian or non-vegetarian is a mandated practice for food products in India. These dots are labeled on the food products’ packaging. However, there is no such system for cosmetics in India that declares their vegetarian or non-vegetarian nature.
- October 6, 2021 Food and Food Supplements, Regulatory Affairs
The Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 was implemented on January 1, 2018.
- September 24, 2021 Medical Devices, Regulatory Affairs
Medical device Post Marketing Surveillance (PMS), an important practice in the entire pharmacovigilance activity, is the process of ensuring the continued safety and efficacy of the device after it is approved and marketed. When the medical device is launched in the market, it is used by a large number of the general population with various medical conditions.
- September 24, 2021 Medical Devices, Regulatory Affairs
Therapeutic Goods Administration (TGA), under the ‘Therapeutic Goods Act 1989,’ is entitled to regulate medical devices placed and marketed in Australia. Medical devices are regulated under the Therapeutic Goods (Medical Devices) Regulations, 2002. Initially introduced in 2002, the regulations underwent multiple amendments at a frequency of at least once a year, almost every year.
- September 20, 2021 Medical Devices, Regulatory Affairs
The medical devices market in Mexico is growing significantly and is expected to reach USD 7.6 billion by 2025. It is considered a tough market in terms of medical device regulations. The Federal Commission regulates medical devices in Mexico for the Protection against Sanitary Risk, i.e., COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios).
- September 20, 2021 Medical Devices, Regulatory Affairs
A Medical Device Establishment Licence (MDEL) is a license issued to Class I medical device manufacturers, importers, or distributors of all device classes. In a recent guidance, Health Canada described how the Agency inspected the licensed medical device establishments, the inspection process and explained how inspectors should assess the compliance with the Food and Drugs Act and Medical Device Regulations.
- September 20, 2021 Medical Devices, Regulatory Affairs
The Medical Device Coordination Group (MDCG) has recently published a joint implementation and preparedness plan for the In Vitro Diagnostic medical devices Regulation 2017/745 (IVDR). It is well known that the IVDR is expected to come into force later in May 2022.
- September 20, 2021 Pharmaceuticals, Regulatory Affairs
Recently, the Director-general – NAFDAC announced the commencement of a Sensitization Campaign in Nigeria. Through this campaign, NAFDAC intends to inform, sensitize and educate the Nigerian citizens about the dangers of intake and use of bogus medicinal products surfacing the market.