Navigating a successful entry into the Chinese pharmaceutical market
30 - January 2023, Princeton, NJ - Martin E. Zuzulo, Managing Director, Americas at Widler & Schiemann, LLC, outlines the challenges and opportunities for US companies entering the Chinese market.
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Expansion of Scope of Temporary Authorizations
1 December 2022 – the Swissmedic published guidance on temporary authorizations.
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Clarification of Terminology for Combination Products (Medicinal Products with a Medical Device Component)
15 December 2022 – the Swissmedic published guidance on clarification of terminology for combination products.
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Updated Swissmedic / Swissethics Position Paper on Decentralized Clinical Trials (DCTs) of Medicinal Products
22 December 2022 – the Swissmedic updated the position paper on decentralized clinical trials of medicinal products.
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Register Medical Devices to Place on the Market
6 December 2022 – the MHRA published updated guidance on the registration of medical devices.
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Medicines: Apply for a Parallel Import License
9 December 2022 – the MHRA published updated guidance on applying for a parallel import license.
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Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards
14 November 2022 – the FDA announced a webinar on 13 January 2023 to discuss standards for reporting ICSRs to FAERS.
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Statistical Approaches to Establishing Bioequivalence
2 December 2022 – the FDA published draft guidance on statistical approaches to establishing bioequivalence for industry.
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ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
2 December 2022 – the FDA published the draft guidance on the abbreviated new drug applications (ANDAs) for industry.
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E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials
5 December 2022 – the FDA published final ICH E19 guidance for industry.
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Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer
6 December 2022 – the FDA published final guidance on PK-based criteria to support the approval of alternative dosing regimens for PD-1 or PD-L1 blocking antibodies for treating cancer patients.
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Drug Products Labeled as Homeopathic
7 December 2022 – the FDA published final guidance on homeopathic drug products for FDA staff and industry.
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Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
9 December 2022 – the FDA published draft guidance on the VMSR program for industry and FDA staff. Submit comments by 7 February 2023.
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Content of Human Factors Information in Medical Device Marketing Submissions
9 December 2022 – the FDA published the draft guidance on medical device marketing submissions for industry and FDA staff. Submit comments by 9 March 2023.
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Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe
14 December 2022 – the FDA published final guidance on failure to respond to an ANDA complete response letter.
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Pulmonary Tuberculosis: Developing Drugs for Treatment
14 December 2022 – the FDA published draft guidance on developing drugs for treatment of pulmonary tuberculosis. Submit Comments by 13 February 2023.
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Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
15 December 2022 – the FDA published the draft guidance for industry on circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection.
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Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
15 December 2022 – the FDA published final guidance on drug labeling for cardiovascular outcome claims for hypertension.
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M11 Clinical Electronic Structured Harmonized Protocol
21 December 2022 – the FDA published draft guidance on the ICH M11 clinical electronic structured harmonized protocol.
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Controlled Correspondence Related to Generic Drug Development
21 December 2022 – the FDA published draft guidance on controlled correspondence related to generic drug development.
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Manual on Borderline and Classification for Medical Devices under Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices
In December 2022 – the European Commission published version 2 of the manual on borderline and classification for medical devices.
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ICH Guideline E8 (R1) on General Considerations for Clinical Studies
2 December 2022 – the EMA published step 5 of ICH Guideline E8 (R1).
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Human Variations Electronic Application Forms (eAF) (DADI) Go-live Q&A Session
6 December 2022 – the EMA published the Q&A guidance on human variations eAF go-live Q&A session held on 27 October 2022 and 8 November 2022.
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EMA EudraVigilance Registration Documents and Manual
7 December 2022 – the EMA published the updated EudraVigilance registration related documents and manual.
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EMA Human Regulatory Update on Medical Devices
8 December 2022 – the EMA updated guidance on medical devices.
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Joint Audit Program for EEA GMP Inspectorates (JAP)
8 December 2022 – the EMA published revision 3 of the audit notification template for EEA GMP inspectorates (JAP).
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Guidance for Applicants/MAHs Involved in GMP, GCP and GVP Inspections Coordinated by EMA
13 December 2022 – the EMA published version 3.1 of guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA.
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Recommendation Paper on Decentralized Elements in Clinical Trials
13 December 2022 – the European Commission published the recommendation paper on decentralized elements in clinical trials, version 01.
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Functional Specifications for the European Database on Medical Devices (EUDAMED)
14 December 2022 – the European Commission published guidance on functional specifications for EUDAMED.
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eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) User Manual
15 December 2022 – the EMA published version 5.8 of the XEVMPD data-entry tool user manual.
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Clinical Pharmacology and Pharmacokinetics: Questions and Answers
16 December 2022 – the EMA published updated Q&A guidance on guideline requirements for parenteral oily solutions.
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Q&A: Good Clinical Practice (GCP)
16 December 2022 – the EMA published updated GCP Q&A guidance.
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Updated IRIS Guide to Registration and RPIs
16 December 2022 – the EMA published updated preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration.
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EU Guideline on Orphan Applications (for Designation and Transfer) - 2022/C 440/02
19 December 2022 – the European Commission published the guideline on orphan applications.
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EMA Clinical Trials Highlights
21 December 2022 – the EMA published Issue 12 of the Clinical Trials Highlights newsletter.
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Clinical Trials Information System (CTIS) – Sponsor Handbook
22 December 2022 – the EMA published version 3.01 of the CTIS sponsor handbook.
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NMPA Announcement on Putting into Use the Electronic Certificates of Documentation for Export of APIs to EU and Certificate of a Pharmaceutical Product
31 October 2022 – NMPA announced putting into use the electronic certificates of Documentation for Export of APIs to EU and Certificate of a Pharmaceutical Product (No. 95, 2022).
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Regulatory Guidelines for Laboratory Developed Tests (LDTs)
24 November 2022 – Singapore Health Sciences Authority (HSA) issued revision one of its regulatory guidelines for LDTs.
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Public Consultation on ICH Guidelines M11 “Clinical electronic Structured Harmonized Protocol (CeSHarP)” and Q5A(R2) “Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin”
28 November 2022 – Swissmedic launched the public consultation on ICH guidelines M11 and Q5A(R2), with a deadline for comments of 26 February 2023 and 10 February 2023, respectively.
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Changes to the Guidance Document Variations TAM HMV4
4 November 2022 – Swissmedic announced an extended reporting time limit of 60 days that applies to variations without assessment.
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Issue of Export Certificates (Free Sales Certificates) for Medical Devices
8 November 2022 – Swissmedic announced the adaptation of the export certificates ordering process for medical devices beginning 1 January 2023.
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MHRA Process for Approving Manufacturing Authorizations or API Registrations in Relation to Unlicensed Cannabis-Based Products for Medicinal Use (CBPMs)
16 November 2022 – MHRA Inspectorate published the blog on MHRA process for approving unlicensed CBPMs.
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Borderline Products: How to Tell if Your Product is a Medical Device and Which Risk Class Applies
16 November 2022 – MHRA updated guidance on medical device borderline products.
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European Commission (EC) Decision Reliance Procedure (ECDRP)
18 November 2022 – MHRA updated guidance on the EC decision reliance procedure.
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Return to International GMP Inspections
8 November 2022 – MHRA Inspectorate published the blog on return to international GMP inspections.
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Access Consortium Good Manufacturing Practice (GMP) Statement
15 November 2022 – MHRA published access consortium statement on GMP inspections reliance and recognition.
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Enforcement Policy Regarding Investigational New Drug (IND) Requirements for Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies
28 November 2022 – FDA published its policy on IND requirements for FMT use.
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Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide
1 November 2022 – FDA published the final Small Entity Compliance guidance on HCT/Ps regulations.
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Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
1 November 2022 – FDA published draft Q&A guidance on expanded access to investigational drugs for treatment use. Submit comments by 3 January 2023.
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S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals
2 November 2022 – FDA published S1B(R1) as an addendum to the current ICH S1 guidance for industry.
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Cross Labeling Oncology Drugs in Combination Regimens
2 November 2022 – FDA published final guidance on cross labeling oncology drugs for industry.
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Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial
4 November 2022 – FDA published final guidance for studies that evaluate multiple versions of a cellular or gene therapy product.
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M10 Bioanalytical Method Validation and Study Sample Analysis
4 November 2022 – FDA published the final guidance on M10 bioanalytical method validation and study sample analysis.
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Sameness Evaluations in an ANDA — Active Ingredients
8 November 2022 – FDA published draft guidance on sameness evaluations in an ANDA. Submit comments by 8 January 2023.
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Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
10 November 2022 – FDA published draft guidance on Q5A(R2) viral safety evaluation of biotechnology products. Submit comments by 14 January 2023.
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Reflection Paper on Criteria to be Considered for the Evaluation of New Active Substance (NAS) Status of Biological Substances
18 November 2022 – EMA published draft guidance on criteria for the evaluation of NAS status of biological substances for consultation. Comments may be submitted until 31 May 2023.
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Annual Report of the Good Clinical Practice (GCP) Inspectors Working Group (IWG) 2021
21 November 2022 – EMA published the annual report of the GCP IWG 2021.
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IRIS Guide to Registration and RPIs
21 November 2022 – EMA published version 2.10 of the preliminary requirements for all IRIS submissions, including substance and research product identifier registration.
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Guidance for Applicants on Simultaneous National Scientific Advice (SNSA) Phase 2 Pilot (from October 2022) – Optimized Process
21 November 2022 – EMA updated the guidance for SNSA phase 2 pilot.
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ICH Guideline Q3C (R8) on Impurities: Guideline for Residual Solvents
28 November 2022 – EMA updated step 5 of the ICH guideline Q3C(R8) on residual solvents.
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Records of Data Processing Activity (public) Regarding the Processing of Personal Data in the Clinical Trials Information System (CTIS)
28 November 2022 – EMA published updated guidance on CTIS data processing activities.
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Union Guidance on Record Keeping and Archiving of Documents Obtained or Resulting from Pharmacovigilance (PV) Inspections
29 November 2022 – EMA published guidance on record keeping and archiving of documents related to EU PV inspections.
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Clinical Trials Information System (CTIS) - Sponsor Handbook
30 November 2022 – EMA published version 3.0 of the CTIS sponsor handbook.
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European Medicines Agency Pre- and Post-Authorization Procedural Advice for Users of the Centralized Procedure
4 November 2022 – EMA updated guidance on pre- and post-authorization procedural advice for users of the centralized procedure.
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Anonymization of Protected Personal Data and Assessment of Commercially Confidential Information during the Preparation of RMPs
4 November 2022 – EMA updated RMP guidance (main body and annexes 4 & 6) for protected personal data and confidential information.
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Procedural Advice for Orphan Medicinal Product Designation
7 November 2022 – EMA updated guidance on the orphan medicinal product designation for sponsors.
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CTIS Training Program Module 07 Updates
8 November 2022 – EMA updated training module 07 of the CTIS step-by-step guide.
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ICH M11 Draft Guideline Reaches Step 2
On 21 October 2022 the ICH announced the ICH M11 draft guidelines reached step 2 of the ICH process.
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ICH E19 Introductory Training Presentation Available
On 25 October 2022 the ICH announced the E19 introductory training presentation available.
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Software and AI as a Medical Device Change Program
On 17 October 2022 the UK MHRA introduced a roadmap for software and AI as a medical device change program.
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Guidance on Pharmacovigilance Procedures
On 25 October 2022 the UK MHRA published the updated guidance on PV procedures.
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Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials
On 17 October 2022 the FDA published the draft guidance on immune-mediated adverse reactions in cancer immunotherapeutic clinical trials for industry.
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Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment
On 17 October 2022 the FDA published the final guidance on acute myeloid leukemia treatment for industry.
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Tissue Agnostic Drug Development in Oncology
On 17 October 2022 the FDA published the draft guidance on tissue agnostic drug development in oncology for industry.
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Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care
On 21 October 2022 the FDA published the draft guidance for industry and FDA staff. Submit comments by 20 December 2022.
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Human Gene Therapy for Neurodegenerative Diseases
On 21 October 2022 the FDA published the final guidance on developing human gene therapy for neurodegenerative diseases.
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Multiple Endpoints in Clinical Trials
On 21 October 2022 the FDA published the final guidance on multiple endpoints in clinical trials for industry.
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Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials
On 31 October 2022 the FDA published the draft guidance on measuring and recording growth and evaluating pubertal development in pediatric clinical trials for industry.
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Quick Guide - Part I & Part II: How to Evaluate a Clinical Trial Application: Assessment and Decision - CTIS Training Program - Module 08
On 24 October 2022 the EMA published the quick guide parts I & II guidance on CTIS training program of module 08, version 1.4.
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ICH Guideline, Clinical Study Protocol Template and Technical Specifications
On 26 October 2022 the EMA published Step 2b of the ICH M11 related guidelines.
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Quick Guide & FAQs: Clinical Study Reports Submission - CTIS Training Program - Module 13
On 28 October 2022 the EMA published Module 13 of the quick guide and FAQs guidance on CTIS training program.
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Swissmedic Inspects Swiss Authorized Representatives (CH-REP)
3 October 2022 — Swissmedic published the report of Swiss authorized representatives (CH-REP) inspections in the first half of 2022 to check implementation of the provisions in the market.
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ICH E19 Guideline Reaches Step 4
4 October 2022 — ICH announced that the ICH E19 guideline reached Step 4 of the ICH process.
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ICH Q5A(R2) Draft Guideline Reaches Step 2
11 October 2022 — ICH announced the ICH Q5A(R2) draft guideline reached Step 2 of the ICH process.
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Export Drugs and Medicines: Special Rules
5 October 2022 — MHRA published guidance on how to get permission to export certain drugs and medicines.
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Exporting Active Substances Manufactured in Great Britain for Use in EEA and Northern Ireland
11 October 2022 — MHRA published guidance on how the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain.
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Apply for Manufacturer or Wholesaler of Medicines Licenses
13 October 2022 — MHRA published guidance on how to apply for manufacturer and wholesale of medicines licenses.
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Medicines: Apply for a Parallel Import License
13 October 2022 — MHRA published the guidance on how to get a parallel import license.
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MORE Registrations - User Reference Guide
4 October 2022 — MHRA published the MORE registration user guide.
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FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
3 October 2022 — FDA published the final PMA guidance on effect on FDA review clock and goals under MDUFA for industry and FDA staff.
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Review of Drug Master Files (DMF) in Advance of Certain ANDA Submissions Under GDUFA
3 October 2022 — FDA published the draft guidance on Type II API DMFs under GDUFA for industry.
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Facility Readiness: Goal Date Decisions Under GDUFA
3 October 2022 — FDA published industry draft guidance on facility readiness for inspection under GDUFA. Submit comments by 6 December 2022.
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Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
3 October 2022 — FDA published final guidance on physical attributes of generic tablets and capsules for industry.
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User Fees and Refunds for Premarket Approval Applications (PMAs) and Device Biologics License Applications (BLAs)
5 October 2022 — FDA published the final guidance on user fees and refunds for PMAs and device BLAs for industry and FDA staff.
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Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments (GDUFA)
5 October 2022 — FDA published final guidance on IRs and discipline review letters under GDUFA.
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Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA
5 October 2022 — FDA published the final guidance on formal meetings between FDA and ANDA applicants for industry.
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Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
5 October 2022 — FDA published final guidance on formal meetings between FDA and ANDA applicants of complex products under generic drug user fee amendments (GDUFA) for industry.
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Competitive Generic Therapies
5 October 2022 — FDA published final guidance on competitive generic therapies for industry.
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Post Market Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
6 October 2022 — FDA published the final post market surveillance guidance for industry and FDA staff.
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Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order
7 October 2022 — FDA published the final PAS guidance for industry and FDA staff.
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