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EMA Guidance: Product Management Services (PMS) – Electronic Submission of Medicinal Product Information
As regulatory systems become increasingly digital, standardized medicinal product data has become essential for improving regulatory efficiency and ensuring consistent information across the European medicines network. To support this transition, the European Medicines Agency (EMA) published the guidance Product Management Services (PMS) – Implementation of ISO Standards for the Identification of Medicinal Products (IDMP) in Europe – Chapter 3: Process for the Electronic Subm
Sharan Murugan
Jun 273 min read
WHO Draft Guidance: Integration of Environmental Sustainability Strategies and Metrics into Pharmaceutical Manufacturing - For Comments
Environmental sustainability is becoming an essential consideration in pharmaceutical manufacturing as production activities consume significant amounts of energy, water, raw materials, and solvents while generating emissions, effluents, and waste. These activities can affect ecosystems, contribute to climate change, and influence long-term public health. To help manufacturers integrate sustainable practices into pharmaceutical operations, the World Health Organization (WHO)
Sharan Murugan
Jun 273 min read
UK MHRA Guidance: Register Medical Devices to Place on the Market
Manufacturers who intend to place medical devices on the market in Great Britain or Northern Ireland must comply with the registration requirements established by the Medicines and Healthcare products Regulatory Agency (MHRA). The Register Medical Devices to Place on the Market guidance explains which devices require registration, who is responsible for registration, applicable timelines, registration procedures, and the associated fees. It also outlines the differences in re
Sharan Murugan
Jun 273 min read