Drug safety is a key issue of people's well-being and public security. It is also vital to public health and social stability. As required by the 12^th Five-year Plan on State Drug Safety, all drugs should meet The 2010 Good Manufacturing Practice (GMP). How will Yangtze River Pharmaceutical Group respond to meet the requirement of the new GMP?

1.        Work Hard to Strengthen Itself

During our 41 years of development, we have met the requirements of The 1998 Good Manufacturing Practice. Over the past 10 years of implementing the 1998 GMP, we have achieved sound and fast growth by constantly improving ourselves, introducing talents, importing equipment, incorporating new ideas on quality control and improving quality control systems. In the second half of 2008, YRPG has launched EU GMP programs on capsules and hard tablets, which not only improved production and quality control of drugs, but also helped itself close the gap between international pharmaceutical giants, laying a solid foundation for further expansion in international market.

In April of 2009, the GMP Research Team of State Food and Drug Administration visited YRPG. Xu Jingren expressed support for the new GMP. He said that the new GMP would be a bold and visionary move to guide domestic pharmaceutical companies in production and quality control of drugs. He also hoped that the new GMP would be implemented as soon as possible.

YRPG has a diversity of products and workshops with over 10 types of over 200 products. Its products range from sterile preparations, such as powder injection and freeze-dried injection, to non-sterile preparations, such as capsules, hard tablets, granules and oral solution, as well as traditional Chinese medicine and chemical raw medicine. Currently over 30 workshops are in operation, with the earliest ones built in the 1990s and latest ones built in the past few years. To expand our capacity and enhance technical standards, YRPG is also building a group of new workshops.

When the new GMP was released and enforced, YRPG set goals of meeting new GMP standards not only for sterile drugs by the end of 2013 but also for non-sterile drugs. YRPG also implemented the new GMP incrementally by drawing experience from EU GMP on the basis of its previous quality control system. YRPG set up special teams, hosted weekly meetings on GMP enforcement and conducted the "Quality Month" activity so that employees could gradually adapt to new standards in the process of learning and improving. By November 2012, 10 workshops from headquarters (with 12 preparations and 6 APIs) have met the new GMP requirements, while 7 workshops from subsidiary companies (with 10 preparations and 1 API) have met the new GMP requirements.

2.        Seek Development against All Odds

In the course of implementing the new GMP, we face problems, some of which can be solved by ourselves, others we have to rely on external environment and resources.

l      Dealing with the Tension between Hardware Upgrade and Market Supply

According to the new GMP, some of the workshops have to upgrade their hardware. However, this could disrupt normal production schedule, and even lead to shortage of supply or loss of market share.

The production and quality control department chose workshops that could possibly meet new GMP standards to apply new GMP. In doing so, they could gain experience and set examples that other workshops could learn from. At the same time, the company is accelerating the construction of workshops to apply new GMP for them, so as to reduce the loss from the upgrade or halting of other workshops. The production department made a plan for workshops that needed renovation to apply new GMP as soon as possible. As more than one workshop can produce the same preparation in YRPG, we could minimize the impact of hardware upgrade on its market share by taking the above-mentioned steps.

l      Dealing with the Tension between Higher Standards and Resource Allocation

As the new GMP in China follows practices from EU GMP and WHO GMP by introducing quality control tools, requirements on software are also very high. To comprehend and carry out new standards is no easy job that can be done in a few days or in a couple of training sessions. We should keep a habit of integrating learning, improving and summarizing. When the documents on quality control are modified, it takes time to allocate resources and train personnel to guarantee the running of the quality control system.

Through one year of practice, we've noticed that, in addition to work hard on our own, we also need good tutors: we need experts on quality control, risk management, and statistics etc.; we need a platform for communication and more ideas to draw on each other's strength. We hope we can have a favorable external surrounding, where the government can allocate social resources, organize training by inviting experts, organize visits and exchanges and help enterprises to better understand the new GMP, so that we can deliver the results and close the gap with international standards.

l      Dealing with the Tension between Rising Cost and Dipping Price

When the new GMP was put into effect, drug prices also had to go up to cover the direct or indirect expense on hardware, higher standards, use of resources, operation and improvement of systems. However, the existing market, including its bidding and pricing, could not demonstrate the quality advantage of GMP-qualified enterprises. Before the deadline of new GMP implementation, these enterprises will face a disadvantage in cost when competing with those who have not applied the new GMP. Moreover, even though the new GMP-qualified companies have standards closer to their foreign competitors, they have no competitive edge on price with them.

As a pharmaceutical company, we expect a reasonable profit while ensuring safe and effective drugs, so that we can continue innovation and sustainable development. Therefore, we hope government agencies can introduce preferential policies regarding the bidding and pricing for new GMP-qualified companies, so as to further promote national pharmaceutical industry.

To sum up, in the face of new GMP, we cannot sit and wait for others' help but work on our own.