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APIC is Mapping API Requirements in Emerging Countries and Working with Them to Create More Transparent, Efficient, and Harmonized Regulatory Processes

The Europe-based Active Pharmaceutical Ingredients Council (APIC) is mapping out the current API registration requirements in emerging countries, defining best practices, and developing strategies for working with the various authorities on creating more transparent, efficient and harmonized regulatory processes....

India Unifying Pharmaceutical Departments

According to the Economic Times of India, the Indian government is planning on bringing all of the government groups that deal with pharmaceuticals under one department. Currently there are numerous separate departments that deal with individual aspects of drugs, such as patenting and licensing. The new department would work to create a more cohesive view […]

Commissioner Hamburg in China

In a FDAVoice blog post about her trip to China in November, FDA commissioner Hamburg discussed the signing of an Implementing Arrangement with the CFDA to “create mechanisms for collaboration on inspections.” Also mentioned was the need for more agency staff in China – a concern of FDA’s in the wake of China’s delay in […]

FDA Revokes Approval for Ranbaxy Generics; Ranbaxy Sues

FDA revoked its 2008 approvals of Ranbaxy’s generic Nexium and Valcyte in early November, following import bans that were placed on the company’s Indian plants after finding them to be non-GMP compliant. Ranbaxy responded to the Nov. FDA action with a suit, stating that the agency had no right to revoke past approvals.

IPQ Monthly Update, October 2014

In focus are: ● the structure/function changes FDA is making to help drive a new pharmaceutical quality regulatory paradigm with closer center/field alignment ● the role that the new Office of Pharmaceutical Quality will play in steering the various significant initiatives that are now in motion, and ● the implementation challenges presented by the new ICH guidelines on elemental impurities (ICH Q3D) and mutagenic impurities (ICH M7), respectively....

CFDA Releases Draft Guideline for Biosimilars

China’s Center for Drug Evaluation (CDE) published a draft guidance in late October on the approval of biosimilars. The guideline creates a system similar to that of the EU with an approved reference product needed to determine biosimilarity through comparison. The guideline requires that at least three batches of a biosimilar be subject to comparability […]

Implementation Challenges for ICH’s New M7 Guideline on Mutagenic Impurities Will Present Themselves at Both the Development and Post-Approval Levels

Among the challenges that will present themselves to pharma companies in implementing ICH’s new M7 guideline on mutagenic impurities is the use of quantitative structure-activity relationship [QSAR] predictions in assessing the risks during development and for post-marketing changes....

Italian Inspectors Find Non-Compliance in Italian and Chinese Plants

The Eudra GMP database indicates that the Italian Medicines Agency issued a statement of non-compliance regarding the I.C.I International Chemical finished pharmaceuticals Cellole, Italy plant in late September. The plant was cited for unauthorized “shadow” production and a lack of product traceability. Equipment maintenance and hygienic practices were also of concern. In late October, the […]

India Reduces Stability Data Requirements

In mid-October, CDSCO established that it would reduce the requirement for long-term stability testing from twelve months to six months. The accelerated stability test requirement will remaining at six months.

CDSCO Increases Personnel to Implement GMP

The Indian drug regulatory agency CDSCO has begun adding inspectors in an effort to increase regulatory oversight. According to Deputy Drugs Controller K. Bangarurajan, India expects “to double the manpower and enhance the lab infrastructure both at the centre and states by the end of 2017.”
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