China's Drug Packaging Material Oversight Gaps Persist as DMMF Plans and Direct-Contact Research Advance

The Current Landscape of Pharmaceutical Packaging Materials in China

At present, several weaknesses remain visible in China's pharmaceutical packaging materials sector: some companies lack fully established production and quality management units, their production quality management systems are incomplete, hardware at pharmaceutical packaging material firms does not always match production scale, and inspection capabilities still fall short of regulatory expectations.

Key causes include pharmaceutical packaging material manufacturers' prolonged neglect of software investment, pronounced departmental silos within companies, a mismatch between testing capacity and quality management needs, and limited technical supervision resources at drug regulatory authorities.

Manufacturers should recognize the importance of pharmaceutical packaging materials and give quality supervision proper priority. Relevant authorities should refine pharmaceutical packaging material regulations and standardize production practices. They should also deepen industry research so supervision is better targeted, set up and improve a quality supervision and sampling inspection mechanism for pharmaceutical packaging materials, strengthen technical oversight of products, and bring production and use practices into a law-based regulatory framework.

Plans to Introduce the DMMF Management System

The DMMF management system has been applied in developed countries to active pharmaceutical ingredients, excipients, packaging materials and chemical intermediates. Recently, Zhang Wei, director of the Drug Registration Department of the State Food and Drug Administration, said that the agency plans to implement this management system.

China currently applies an approval system mainly to active pharmaceutical ingredients and packaging materials, while a dossier management system is more common abroad. Under that system, manufacturers of pharmaceutical packaging materials, excipients and raw materials create dossiers and supply relevant information to formulation companies, and the government conducts registration review through those dossiers; when a formulation is reviewed, only one DMMF number is needed for the APIs and excipients under review. A dossier normally has a public part and a non-public part. The non-public part is often a company's core confidential information, which firms are reluctant to give to formulation makers when selling products, so this portion is required to be kept with the government.

China should actively explore a DMMF system suited to its national conditions, extend the reach of supervision and management, strengthen formulation manufacturers' management of APIs, excipients and packaging materials, and require formulation manufacturers to audit raw materials, excipients and related inputs.

Research Launched on Packaging Materials in Direct Contact with Drugs

Commissioned by the Drug Registration Department of the State Food and Drug Administration, the China Pharmaceutical Packaging Association has officially launched a research initiative on the current status of packaging materials and containers that come into direct contact with drugs. The initiative will run for one year and ultimately produce a related research report, providing recommendations for government departments as they formulate a pharmaceutical packaging material policy and regulation system suited to China's national conditions.

The research mainly examines the basic situation of existing pharmaceutical packaging material and drug manufacturers and pharmaceutical packaging material testing institutions at all levels, along with how regulators at each level supervise production, distribution and use. It also compares domestic and foreign management systems, studies and explores the creation of a scientific and reasonable regulatory system suited to China's national conditions, and sets near-term and long-term goals for pharmaceutical packaging supervision in China. This research is the first of its kind in the history of the pharmaceutical packaging industry and represents foundational work for the industry's long-term development.

-- This article is reprinted from China Packaging Network (pack.cn), original link: http://news.pack.cn/show-362291.html