Procedure: MA RenewalCountry: Global ProcedureVersion #: 01/17/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-MD-PhR-SRCategory: Pharmaceuticals/MD&IVDValidity: Lifetime in most countriesCertified by: Vlad Reznikov Copyright: Pattern of USA Inc. …
Procedure: Ongoing Pharmacovigilance ServiceCountry: Global ProcedureVersion #: 01/23/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-OPS-SRCategory: PharmaceuticalsValidity: AnnualCertified by: Vlad Reznikov Copyright: Pattern of USA Inc. …
Procedure: Sunset Clause and MA closing activity Country: Global ProcedureVersion #: 01/05/2024Author: Vlad ReznikovEditor: Daria Kostiuchenko ID: GP-PhR-CSR-SRCategory: Pharmaceuticals/MD&IVDValidity: ImmediateCertified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY A sunset clause refers to a regulatory provision that sets a predetermined expiration date or termination point for the marketing authorization of a product. This clause…
Procedure: Randomized Labeling for CRO Country: Global ProcedureVersion #: 01/05/2024Author: Vlad ReznikovEditor: Daria Kostiuchenko ID: GP-PhR-RND-SRCategory: Pharmaceuticals/MD&IVDValidity: Upon requestCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY In drug development conducted by Contract Research Organizations (CROs), randomized labeling involves the assignment of unique codes or labels to investigational drug products in a random manner. This…
Procedure: Commercial Ad, Labeling and Health Claims Compliance Check Country: Global Procedure Version #: 01/05/2024 Author: Vlad Reznikov Editor: Daria Kostiuchenko ID: GP-PhR-CLH-SR Category: Pharmaceuticals/MD&IVD/Others Validity: Until next NRA update Certified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY A Commercial Ad, Labeling, and Health Claims Compliance Check for healthcare products involves a thorough…
Procedure: REMS and ETASU DevelopmentCountry: United StatesVersion #: 01/05/2024Author: Vlad ReznikovEditor: Daria Kostiuchenko ID: US-PhR-RMS-SRCategory: PharmaceuticalsValidity: Next FDA call for actionCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY The FDA may require Risk Evaluation and Mitigation Strategies (REMS) and Elements to Assure Safe Use (ETASU) for drugs with specific safety concerns. REMS and ETASU…
Procedure: Line (MA) Extension Country: Global ProcedureVersion #: 01/04/2024Author: Vlad Reznikov Editor: Daria Kostiuchenko ID: GP-PhR-LXT-SRCategory: PharmaceuticalsValidity: Until next MA expiration or updateCertified by: Vlad Reznikov Copyright: Pattern of USA Inc. …
Procedure: Generic Drug (ANDA) New MA Country: Global ProcedureVersion #: 01/04/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-AND-SRCategory: PharmaceuticalsValidity: Reg. 5 YearsCertified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY Generic products undergo rigorous bioequivalence studies to establish their similarity to the reference listed drug (RLD), affirming pharmaceutical and therapeutic equivalence. The generic drug must exhibit…
Procedure: Type II variation approval Country: Global ProcedureVersion #: 01/03/2024Author: Mariya IvanovaEditor: Daria Kostiuchenko ID: GP-PhR-VII-SRCategory: PharmaceuticalsValidity: Until next MA expiration or updateCertified by: Vlad Reznikov Copyright: Pattern of USA Inc. …
Procedure: Type IB variation notifications Country: Global ProcedureVersion #: 01/03/2024Author: Mariya IvanovaEditor: Daria Kostiuchenko ID: GP-PhR-VIB-SRCategory: PharmaceuticalsValidity: Until next MA expiration or updateCertified by: Vlad Reznikov Copyright: Pattern of USA Inc SUMMARY A Type IB variation is characterized as a variation that does…
Procedure: Non-clinical data SEND conversionCountry: Global ProcedureVersion #: 01/03/2024Author: Vlad ReznikovEditor: Daria Kostiuchenko ID: GP-PhR-SND-SRCategory: PharmaceuticalsValidity: Until SubmissionCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. …
Procedure: CARES Act Reporting Country: United States Version #: 01/03/2024 Author: Vlad Reznikov Editor: Daria Kostiuchenko ID: US-PhR-CRS-SR Category: Pharmaceuticals/Others Validity: Annual Reporting Certified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY The U.S. FDA CDER NextGen Portal Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Reporting initiative streamlines and enhances the reporting process,…
Procedure: Type IA and IA-IN variation notificationsCountry: Global ProcedureVersion #: 01/03/2024Author: Mariya IvanovaEditor: Daria Kostiuchenko ID: GP-PhR-VIA-SRCategory: PharmaceuticalsValidity: Until next MA expiration or updateCertified by: Vlad…
Procedure: Innovative Drug MA (Novel NDA)Country: Global ProcedureVersion #: 12/07/2023Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-NDA-SRCategory: PharmaceuticalsValidity: Lifetime/5 years/country-specificCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY The New Market Authorization (MA) for Innovative Drug Registration, known as Novel NDA, is a regulatory process facilitating the approval and introduction of new and innovative drugs to the market. This process involves a comprehensive assessment of…
Procedure: Investigational IND ApplicationCountry: Global ProcedureVersion #: 12/07/2023Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-IND-SRCategory: PharmaceuticalsValidity: Until MA obtaining or NRA updateCertified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY The first step of any…
Procedure: NRA ClassificationCountry: Global ProcedureVersion #: 11/28/2023Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-CLS-SRCategory: PharmaceuticalsValidity: Until MA obtaining or NRA updateCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY Divergent classification by national regulatory agencies is pivotal for companies to align with the distinct requirements of each target market. In the realm of regulatory affairs, it plays a crucial role…
Procedure: Authorized RepresentativeCountry: Global ProcedureVersion #: 11/30/2023Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-AR-SRCategory: PharmaceuticalsValidity: 1 year with optional extensionCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY Legally Authorized Representative (AR, LAR, or US Agent in the United States) is a local person or legal entity appointed by foreign manufacturer to act on their behalf regarding certain regulatory obligations under local…
Procedure: Pre-Sub ActivitiesCountry: Global ProcedureVersion #: 11/30/2023Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-PSA-SRCategory: PharmaceuticalsValidity: Until SubmissionCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY Pre-Sub Activities refer to the regulatory activities conducted by an National Regulatory Agency (NRA) prior to the submission of a marketing authorization application for a medicinal product.These activities aim to ensure that the…
Procedure: Regulatory Compliance and Gap AnalysisCountry: Global ProcedureVersion #: 11/27/2023Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-GAP-SRCategory: PharmaceuticalsValidity: Until MA ApplicationCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY Gap analysis involves assessing and identifying any shortcomings or gaps in a registration dossier compliance with local regulatory standards. These gaps could include missing documentation, incomplete testing, or lack of adherence to specific guidelines. Unlike risk…
Procedure: Intellectual Property Rights ProtectionCountry: Global ProcedureVersion #: 11/28/2023Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-IP-SRCategory: Pharmaceuticals/MD&IVD/OthersValidity: IP Rights Expiration DateCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY Intellectual Property Rights Protection in pharmaceuticals registrations refers to the legal mechanisms and regulations in place to safeguard the intellectual property of pharmaceutical companies. This includes patents, trademarks, copyrights, and trade secrets…
Procedure: Regulatory Intelligence Country: Global Procedure Version #: 11/28/2023 Author: Daria Kostiuchenko Editor: Daria Kostiuchenko ID: GP-PhR-RI-SRC Category: Pharmaceuticals/MD&IVD/Others Validity: Until next NRA update Certified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY Regulatory Intelligence involves up-to-date gathering, analysis, and interpretation of information regarding regulations and compliance requirements. Strategic consulting involves providing expert advice…