Regulatory publishing involves a complex web of Country-specific health authority requirements that must be met before any product can be commercialized. The documentation includes clinical trial data, safety data, manufacturing processes, and labeling information, among other things.
- September 20, 2023 Regulatory Contract Staffing, Pharmaceuticals, Publishing & Submissions
- September 14, 2023 Pharmaceuticals, Regulatory Artwork Services
The pharmaceutical industry plays a crucial role in ensuring the well-being and health of people worldwide. In this highly regulated sector, packaging plays an essential role in maintaining the safety, efficacy, and integrity of pharmaceutical products. Pharmaceutical packaging is a complex and highly regulated industry.
- September 13, 2023 Pharmaceuticals, Publishing & Submissions
China has been gradually adopting eCTD submissions since 2017. In 2022, the National Medical Products Administration (NMPA) announced that it would be fully transitioning to eCTD submissions by the end of 2023. This means that all new drug applications submitted to the NMPA must be in the eCTD format.
- September 7, 2023 Pharmacovigilance, Regulatory Labeling
In the pharmaceutical industry, ensuring patient safety is paramount. As new medications are developed and introduced into the market, it becomes crucial to provide accurate and comprehensive information to healthcare professionals and patients. This is where labeling and pharmacovigilance play a pivotal role.
- September 6, 2023 Cosmetics Regulatory Services, Regulatory Affairs, Regulatory Labeling
Given the dynamic landscape of the cosmetic industry, it is important to understand the Regulatory framework of different countries. Indonesia, a country known for its rich cultural heritage and diverse market, presents a unique set of challenges and opportunities for cosmetic manufacturers and distributors.
- September 5, 2023 Regulatory Affairs, Publishing & Submissions, Regulatory Software & Services
In today's rapidly evolving pharmaceutical landscape, regulatory compliance plays a pivotal role in ensuring medicinal products' safety, efficacy, and timely availability. Regulatory submissions are critical to this process, requiring pharmaceutical companies to navigate complex frameworks and meet stringent requirements.
- August 30, 2023 Medical Devices, Regulatory Affairs
An Overview of Document Registration for Medical Devices in Turkey
In Turkey, document registration is a crucial step in obtaining Regulatory approval for medical devices. The Türkiye İlaç ve Tıbbi Cihaz Kurumu (TITCK), or the Turkish Medicines and Medical Devices Agency, oversees this process, ensuring strict adherence to the country’s regulations and standards.
- August 30, 2023 Medical Devices, Regulatory Affairs
Introduction
Medical device classification with the Ministry of Health and Prevention (MOHAP) in the United Arab Emirates (UAE) is vital for ensuring patient safety, achieving Regulatory compliance, and determining registration requirements. The classification is risk-based, with four (04) types (Class I, IIa, IIb, and III), and is overseen by MOHAP’s Registration and Drug Control Department.
- August 30, 2023 Medical Devices, Regulatory Affairs
Medical device grouping in India is a Regulatory process that enables manufacturers and importers to register multiple devices under a single license. Regulated by the Central Drugs Standard Control Organization (CDSCO), the grouping guidelines specify how companies can group their medical devices for import or manufacture clearance.
- August 30, 2023 Medical Devices, Regulatory Affairs
The Guidelines for Registration Review of Radio Frequency (RF) beauty devices in China is a consolidated document that guides registration applicants and technical review departments on how to prepare registration application materials for RF beauty devices.