• TGA Standards for Personal Protective Equipment (PPE)

    COVID-19 outbreak necessitated an extensive study on the Personal Protective Equipment (PPE) regulations. Depending on the PPEs’ (face masks, gloves and gowns) therapeutic purpose, TGA has designed certain guidelines for manufacturers, consumers and healthcare professionals.

    Reliant to the therapeutic use, some PPEs are included in the Australian Register of Therapeutic Goods (ARTG)...

  • EU MDR Implementation Deadline Postponed for One Year

    In the light of the international health crisis, on April 17, 2020, the European Commission (EC) proposed a one-year delay in the adoption of the new European Union Medical Device Regulations (EU MDR). Originally, the set of regulations were supposed to come into force by May 26, 2020. Considering the current global scenario and the shortage of devices and other medicinal products, the EC...

  • FDA Guidance for Manufacturing Hand Sanitizers
    May 8, 2020 Regulatory Affairs

    The outbreak of coronavirus has become a global threat. With gradual spreading and increase in the number of infected persons, the COVID-19 has created a state of Public Health Emergency. To overcome this pandemic and ensure the safety of people, life sciences manufacturers all over the world are working continuously towards developing vaccines and solutions. However, in the meantime, the...

  • FDA’s New COVID-19 SPL Templates & Pre-requisites

    The COVID-19 pandemic has disrupted all the industries across the world. To handle the situation carefully, certain proactive measures have already been rolled out. One among them is to properly sanitize the hands with over the counter available drugs such as Hand rubs and Hand Sanitizers. To make such products adequately available in the market, the United States Food and Drugs Administration...

  • EMA Prefers Electronic Certificate Provision Over Printed Copies
    May 4, 2020 Regulatory Affairs

    With the prevailing COVID-19 pandemic, the Regulatory bodies are propelled to take quick and flexible Regulatory actions. Accordingly, EMA has called for a new system of issuing electronic certificates for human and veterinary medicines. Proposedly, the Agency will no longer provide printed certificates, but only the electronically signed and authenticated certificates. The EMA’s certification...

  • Immunity Boosting Supplements & The Need of Quick Market Entry

    With the number of ailments and stress levels rising in the current scenario, people are willing to instantly boost their immunity levels. But for most, the regular diet is far from building up the necessary. While most of us are able to get our nutrients from a healthy diet, many are still struggling to manage a well-balanced or planned diet and that is causing the rise of vitamin...

  • CDSCO Fast Tracks Regulatory Approvals For COVID-19 IVD Kits

    Ever since the World Health Organization (WHO) has declared the COVID-19 outbreak as a pandemic, the global health authorities and life sciences organizations are quickly responding to the situation to see how they can make meaningful contributions.

    Given the significance of ‘Testing’ in these extraordinary times and to align with the increasing demand for more COVID-19 diagnostic kits...

  • FDAs Expedite Regulatory Pathways for Medical Emergencies
    April 7, 2020 Regulatory Affairs

    While the world is tussling with COVID-19 pandemic, there’s an emergency need for its treatments and vaccines. Though, currently, there is no FDA approved therapy or vaccine for COVID-19, the agency has several tools to expedite the review and approval of a COVID-19 biologic treatment or vaccine, after it emerges.  

    FDAs Tools

    The rising concerns of COVID-19 outbreak,...

  • 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...

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