ARTICLES BY PETER H. CALCOTT

• EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance

  8/6/2025

  The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

• 7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies

  7/3/2025

  The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.

• MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs

  3/11/2025

  The U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies (advanced therapeutic medicinal products), describing modular and point of care manufacturing. It becomes effective July 23, 2025.

• FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics

  12/11/2024

  FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025.

• EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides

  9/26/2024

  The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.

• Strategies To Tackle CAR-T Product Challenges

  6/24/2024

  This article describes strategies for scaling up production of CAR-T products, including the hub model, bedside model, innovation of process strategy, and more.

• FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities

  12/5/2023

  In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.

• FDA Introduces Quality Management Maturity Program

  9/26/2023

  The FDA program described in a new document, CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, is a next logical step to drive better quality, more predictable outcomes, and supply chain assurance.

• EMA's Revised GMP Annex 1 Addresses Common Global Challenges For Sterile Products

  1/18/2023

  The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.

• 9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations

  9/22/2021

  The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.