• 3 Major Challenges of Structured Product Labeling(SPL), US FDA

    In January 2006, the United States Food and Drug Administration (US FDA) introduced Structured Product Labeling (SPL) format for submitting product and facility information and changes to label submissions. The shift towards the new electronic format was aimed at uniformly informing patients, physicians, pharmacists, and the agency about the label content. When...

  • Cosmetics Market and business opportunities in South Korea

    The Korean beauty market is valued at USD 13 billion, making it one of the top 10 beauty markets in the world and offering a pool of business opportunities for manufacturers. Most of the brands are successful in South Korea because rather than sticking to the classic brands, consumers prefer trying new products to suit their daily skin care routine. Be it customized products or textured...

  • FDA extends deadline for Type III DMF submissions in eCTD format

    For the third time in a row, the United States Food and Drug Administration (USFDA) has extended the compliance date for Type III Drug Master Files (DMFs) to be submitted in electronic Common Technical Document (eCTD) format. With the deadline extended till May 5, 2020, the first and foremost question every applicant should ponder upon is, what are the DMF Type III requirements and how is the...

  • Cosmetics Compliance and Emerging Technologies

    When it comes to personal care and cosmetic products, cosmetic manufacturers must adhere to the safety and efficacy Regulations to make sure their products are safe for consumption. But, with their continuous focus on new inventions to meet the market and competitive demands of consumers’ ever-growing beauty consciousness and their ingredient choices, manufacturers may miss out keeping a tab...

  • 8 new medical devices added to list of CDSCO's regulated medical devices in India

    Do you know? Out of 5000 types of medical devices marketed in India, only 23 types are currently regulated by the Central Drugs Standards Control Organization (CDSCO). To increase the ambit of Regulatory supervision and ensure efficacy and safety of medical devices, in early 2017, the CDSCO drafted and published the Medical Device Rules – 2017, which were made mandatory from January 1, 2018....

  • Re-classification of spinal implantable device by Australia's TGA
    March 11, 2019 Medical Devices

    Australia’s Therapeutic Goods Administration (TGA) published a consultation paper on 11th February 2019 to receive effective feedback from the industry regarding the proposal of reclassifying spinal implantable medical devices to a higher level of classification. The proposal is an effort by the TGA to align its Regulatory requirements with that of the European Union’s Medical Device...

  • Medical device Modernization of 510(k) clearance, a pathway on Safety & Performance
    March 7, 2019 Medical Devices

    Did you know? The US Food and Drug Administration (FDA) has set yet another high record by approving 106 novel devices in 2018, making it the most successful year for medical devices. With this accomplishment, FDA has surpassed its 40-year old record set in 2017 of approving 99 novel devices, showing a continuous growth for the past 8 years. The approved devices include a range of innovative...

  • Brexit: Artwork Challenges for Pharma Industry

    The impact of Brexit is evident in almost every industry based in the European Union (EU) and the United Kingdom (UK). Pharmaceutical industry too not to be spared. Although the UK is in negotiations with the EU to streamline the transitions, the European Medicines Agency (EMA) has requested the pharmaceutical marketing authorization holders (MAHs) to stay prepared in advance to ensure...

  • Growing demand for halal products

    The demand for cosmetics and personal care products is rising exponentially across the world. Because of this rise in demand, trends related to the products, like vegan and organic, are prevailing now more than ever. One such trend is Halal products.

    But is there really scope for such products in the market? The answer is a definite yes! According to surveys, the global halal cosmetics...

  • Health Canada's action plan on Medical Devices
    February 20, 2019 Medical Devices

    Health Canada (HC) has one of the most stringent regulations for medical devices. To further increase the safety and effectiveness of devices, and optimize the health outcomes for end-users, the Canadian health authority (HA) is aiming to strengthen the current Regulatory framework. The three-part strategy announced recently as an action plan is the part of the same. The aim of the action plan...

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