• Managing Label Compliance in a Highly Complex Supply Chain

    The pharmaceutical supply chains are highly complex, with multiple stakeholders like manufacturers, suppliers, technology providers, packaging partners, and retailers obliged to maintain the Regulatory standards for quality, safety, and procedural accuracy throughout the product lifecycle. As each product moves down the supply chain, stakeholders involved at every level of the product...

  • Mandatory Submissions through CESP in Cyprus - Key Considerations

    Being a Member State of the European Union (EU), the Republic of Cyprus through the Department of Pharmaceutical Services has mandated the submission of the medicinal products for human use through the Common European Submission Platform (CESP).

    The CESP is an initiative available for all the EU Member States, authorization applicants and holders, and for both human and veterinary...

  • CDSCO Amends the Medial Device Rule 2017
    February 28, 2020 Medical Devices

    To strengthen the regulations of medical devices in India, the Central Drugs Standard Control Organization (CDSCO) has released two final amendments to the Medical Device Rule 2017. The amendments are expected to provide more clarity on the scope of medical devices and establish an expedited registration route for certain devices. The CDSCO has announced that both the amendments will come into...

  • EU MDR and its Impact on Device Labeling and Artwork

    To ensure high standards of quality and safety for medical devices being produced or supplied, the European Union (EU) has released a new Medical Device Regulation (MDR) in May 2017. As the three-year transition period for medical device manufacturers will come to an end from May 26th, 2020, organizations must relook at implementing compliant processes and procedures accordingly....

  • Post-Brexit Updates for Pharma and Device Manufacturers
    February 27, 2020 Medical Devices, Pharmaceutical

    On January 31, 2020, the United Kingdom (UK) officially left the European Union (EU) making the Brexit come alive. In the light of Brexit, the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have released certain Regulatory guidelines to ensure both pharmaceutical and medical device manufacturers are ready for the transition period. Here are...

  • Labeling Compliance in the EU – Insightful Webinar
    February 27, 2020 Regulatory Labeling

    It is evident that the labeling requirements in the European Union (EU) are quite dissimilar, given various region-specific regulations across the 27 member states. Besides this, the emerging European Regulatory landscape demands life sciences manufacturers to be more cautious in implementing and showcasing the safety information.

    In the status-quo, to sail through the European market...

  • EAEU’s Decisions on Electronic Submissions - A Comprehensive Report for Drug Applicants
    February 27, 2020 Publishing & Submissions

    On August 3, 2017, the committee of the Eurasian Economic Union (EAEU) published the standards for electronic submissions of drug applications. With respect to same, the Board of the Eurasian Economic Union released two important ‘Decisions’ on the electronic submission format, which mandates the applicants to provide more detailed information. What are these ‘Decisions’ and guidelines related...

  • MFDS To Review Draft Amendments to South Korean Cosmetics Act

    To strengthen the cosmetic product regulations in South Korea, the Ministry of Food and Drug Safety (MFDS) introduced six draft amendments in 2019. The amendments focus on various Regulatory aspects of cosmetic products such as manufacturing, scrutiny, labeling etc. The purpose of proposing these amendments is to ensure the distribution of safe and effective cosmetic products in South Korea...

  • Brexit and The Facelift of the UK’s Cosmetic Regulations

    Brexit is just around the corner and the United Kingdom (UK) is all set to leave the European Union (EU). The implementation date of Brexit was yet again postponed to January 31, 2020, after the UK requested more time for preparations. However, if the UK and the EU are able to ratify a withdrawal agreement by the time of Brexit, the UK will have a transition period until December 31, 2020, to...

  • Roles and Responsibilities of An EU Qualified Person
    January 30, 2020 Regulatory Affairs

    Thanks to the evolving global Regulatory landscape! Each country now has its own, defined regulations and requirements in governing the quality, safety, and efficacy of the medicinal products entering or being manufactured in their market. In this scenario, it is necessary for organizations to know about specific Regulatory requirements of their targeted markets. If their targeted market is EU...

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