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Post-Authorization Safety Studies (PASS): A Regulatory Imperative After Approval

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Marketing authorization does not end a medicine’s safety evaluation. Once products enter real-world use, broader patient exposure and long-term treatment can reveal risks not fully identified in clinical trials. Regulators therefore rely on Post-Authorization Safety Studies (PASS) to address post-approval safety uncertainties. PASS are structured pharmacoepidemiological or clinical studies conducted to evaluate identified or potential risks, assess risk-minimization effectiveness, and generate real-world safety evidence. Across the EU, US, UK, and other major markets, mandatory PASS are now embedded in regulatory frameworks and enforced as legally binding obligations. Authorities increasingly assess not only study outcomes, but also protocol governance, reporting discipline, and inspection readiness. As a result, PASS has evolved from a post-approval formality into a critical component of lifecycle pharmacovigilance and approval sustainability. Read in detail here: Post-Authorization S...
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Resolving US FDA Prescribing Information (PI) Deficiencies During ANDA Review

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  During the evaluation of an Abbreviated New Drug Application (ANDA), the US FDA issued a series of review comments covering multiple sections of the submission. A substantial portion of these comments focused on  Prescribing Information (PI) , reflecting the agency’s heightened expectations for labeling accuracy, internal consistency, and traceability to supporting data. Recognizing the regulatory sensitivity of PI deficiencies and the potential impact on approval timelines, the applicant engaged external regulatory expertise to manage and resolve the observations in a structured and compliant manner. Client Need The applicant required specialized regulatory support to: Interpret and respond to complex US FDA PI-related observations Execute extensive revisions to the Prescribing Information Maintain consistency between PI statements and underlying ANDA data Avoid further rounds of FDA queries or review delays The priority was to achieve  first-cycle closure of PI defici...
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Why Supplier Compliance and Audit Management Is Non-Negotiable in Global Healthcare Supply Chains

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In today’s interconnected world, pharmaceutical and medical device companies depend on a complex web of suppliers that span continents. This global expansion unlocks access to specialized materials, niche manufacturing expertise, and operational efficiencies,   but it also introduces heightened regulatory obligations and oversight risks. Regulators no longer tolerate weak supplier control as a siloed or back-office task. Rather, global oversight of supplier compliance and audit processes has become central to quality systems governance,  an essential strategy that protects product quality, safeguards patient safety, and maintains market access. Regulatory Imperatives: Oversight Without Delegation Across major quality frameworks  from ICH Q10 to EU GMP, ISO standards, and the U.S. FDA’s GMP requirements,   the responsibility for supplier performance lies squarely with the product owner. Authorities are clear: manufacturers cannot outsource accountability. Inadequate supplier control fre...
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Strengthening Drug Safety: The Strategic Role of Pharmacovigilance Audits with DDReg Pharma

  In the pharmaceutical industry, compliance is not a static destination but a continuous journey of oversight. As regulatory authorities like the FDA, EMA, and MHRA intensify their scrutiny, the robustness of your pharmacovigilance (PV) system becomes your strongest defense. A  Pharmacovigilance Audit Services    is the proactive mechanism that ensures your safety data, processes, and systems are not only compliant but high-performing. DDReg Pharma  provides comprehensive, risk-based audit and compliance services designed to identify gaps before they become regulatory “showstoppers.” Why a “Risk-Based” Audit Strategy is Essential The complexity of modern drug safety—ranging from clinical trial monitoring to post-market surveillance—demands a focused approach.  DDReg Pharma  employs a risk-based audit methodology, prioritizing high-risk areas such as critical safety processes, vendor oversight, and the integrity of the  Pharmacovigilance System Ma...
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AI & NLP: Redefining Regulatory Document Management in Life Sciences

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  In today’s fast‑paced regulatory landscape, managing huge volumes of documentation from clinical trial reports to quality records and submission dossiers remains one of the biggest challenges for regulatory teams. Traditional manual processes are slow, error‑prone, and resource‑intensive. That’s where  Artificial Intelligence (AI)  and  Natural Language Processing (NLP)  come in. Here’s why this matters: AI accelerates document review by processing vast content quickly and flagging gaps. NLP enables machines to “understand” and extract insights from text — turning unstructured PDFs into searchable knowledge. Semantic search and automated indexing empower teams to find critical information instantly. Predictive insights from historical data help anticipate regulatory challenges and streamline strategy. Centralised AI‑driven platforms improve cross‑functional collaboration and audit readiness. But effective adoption isn’t plug‑and‑play. Success depends on: 🔹 St...
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Regulatory Trends That Will Shape 2026 Submissions

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The regulatory trends below show how 2026 will influence submission planning across  pharmaceuticals ,  biologics , combination products,  medical devices , and advanced therapies. 1. Global Alignment on Benefit–Risk Frameworks 2. Expansion of IDMP-Based Data Exchange 3. Greater Use of AI-Augmented Dossier Screening by Regulators 4. Rising Expectations for Real-World Evidence (RWE) 5. Stronger Governance for Decentralised and Hybrid Clinical Trials 6. Expansion of Sustainability-Linked Compliance Requirements 7. New Convergence in GMP and GDP Expectations 8. Growth in Interoperable e-Labeling and Digital Information Delivery 9. Strengthening of Post-Market Performance Reporting 10. Increased Scrutiny of Manufacturing Process Variability 11. Harsher Non-Compliance Penalties for Data Integrity Breaches 12. Broader Oversight for AI-Enabled Medical Technologies DDReg Capability DDReg guides companies through rapidly evolving 2026 requirements with precise  r...
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Japan Aligns Generic Drug Regulation With ICH Standards-What This Means for Global Pharma?

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  Regulatory Affairs Services for Generics in Japan Japan’s  Ministry of Health, Labour & Welfare (MHLW)  and the  Pharmaceuticals and Medical Devices Agency (PMDA)  have taken a major step in harmonising generic drug regulation with  International Council for Harmonisation (ICH)  quality expectations. This shift extends key ICH guidelines including stability (e.g., ICH Q1 series) and impurity standards to generic pharmaceutical submissions in Japan. Why this matters:  Generic drug dossiers now must include  ICH-aligned quality data , including long-term stability studies tailored to Japan’s climatic conditions.  Applicants must use the  ICH CTD structure  (Modules 2 & 3) for consistency with global submissions.  Early  PMDA engagement  is key for clarifying expectations and avoiding review delays. Strategic impact for manufacturers:  Drives  regulatory convergence  with major markets (US, ...
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