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India State Approval Times

India’s largest state, Maharashtra, has cut the time its FDA takes to process manufacturing licensing applications and “slashed” its backlog by adopting an online system, The Asian Age reported in early April. Over the six months the agency has used the system, it says that it has cleared 15,000 applications. Maharashtra’s FDA has implemented an […]

India Exploring PIC/S Membership

India’s Ministry of Commerce and Industry met with pharmaceutical companies in April to discuss joining the multinational Pharmaceutical Inspection Cooperation Scheme (PIC/S), The Economic Times of India reported. It notes that large pharma firms favor the move because it “would expand export markets,” while smaller companies expressed concern that they would have to meet stricter manufacturing […]

Bar Codes on Drugs Exported from India

India will require that individual cartons of drugs for export contain bar codes designating their source, The Economic Times of India reported in April. The requirement takes effect in July and is intended to ensure that drugs manufactured illegally in other countries cannot be labeled as coming from India. A proposal to require bar codes […]

Online GMP Training in India

U.S.-based Underwriters Laboratories will offer online GMP training to drug inspectors in India, Pharmabiz reported in early April. In addition to GMPs, training will cover GLPs and clinical research topics. The training “would definitely help our inspectors understand the nuances of global regulatory requirements and ensure a high degree of quality control for pharmaceutical manufacturers […]

Data Integrity Laws in India

The Indian health ministry is planning to rewrite legislation covering the integrity of data submitted in regulatory applications to include penalties for those who violate the rules, PharmaBiz reported in April. While the current law states that data submitted must be authentic and certified, it does not contain a legal basis for punishing offenders. Problems […]

EDQM/USP Monograph Harmonization

The European Directorate for the Quality of Medicines and Healthcare (EDQM) and the United States Pharmacopeial Convention (USP) have jointly decided to halt the 2008 “Prospective Harmonization Pilot Project” initiated to develop harmonized monographs and reference standards for drug substances still under patent. The joint press release notes that the collaboration “revealed complexities” as USP […]

Intermediaries in China Drug Approvals

The Chinese government has moved to curtail the use of intermediary service providers in the approval process for drugs and other products, Xinhua news service reported in April. Firms seeking to register drugs in China often use third parties to help them in the process. According to the Xinhua report, such intermediaries are viewed by […]

IPQ Monthly Update, March 2015

During March, IPQ focused on the dialogue that has been intensifying at public forums on the daunting manufacturing and control challenges regulators and industry face in guiding the expanding array of cell and gene therapy (CGT) products now under development to commercialization. The five stories in the Monthly Update for March explore the CMC issues the new therapies pose from the European, US and Asian perspectives and where the emerging approaches are converging and diverging. Two of the stories delve further into the especially challenging but critical task of developing potency assays for the advanced therapies, and another spotlights Novartis’ advancing efforts to adapt biotech manufacturing and control technology and systems to make CGT commercialization a reality....

Regulatory Approach to Manufacturing and Control of Cell/Gene Therapies Draws International Discussion

Regulators around the world have been taking the opportunity at recent international forums to benchmark on their respective efforts to create a viable framework for regulating the manufacturing and control of cell/gene/tissue therapies and to consider harmonization possibilities....

IPQ Monthly Update, January/February 2015

During January and February, IPQ explored several impactful initiatives that are underway in different areas of the pharmaceutical manufacturing and control arena to create standards and databases that will make both industry and regulators more effective and allow them to communicate better.  These include the efforts of: ● the industry-driven Allotrope Foundation to create lab data standards and the “lab of the future”● FDA in cooperation with industry to continue to implement the 2013 Drug Supply Chain Security Act ● regulators, industry and academia to upgrade pharmaceutical excipient databases, and ● Asian regulators, in line with those in the US and Europe, to address a new generation of regulatory challenges....
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