Pioneers International Trading Ltd.

The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.

The products in question include:

• Lisinopril (20 milligrams)
• Guaifenesin/Dextromethorphan (600 mg and 1000 mg)
• Gabapentin (100 mg, 300 mg and 400 mg)
• Metoprolol (50 mg)
• Nifedipine (30 mg)
• Diclofenac Sodium (30 mg)
• Glucophage (500 mg Extended Release)
• Glucovance (125 mg and 500 mg)
• Glipizide/Metformin (2.50 mg/250 mg)
• Furosemide (20 mg)
• Tamoxifen Citrate (10 mg)
• Metformin HCl ER (500 mg)
• Calcitrol (0.25 micrograms)

The FDA has no evidence that any other Medicine Shoppe pharmacies outside of the 8035A Liberty Road and 5900 Reisterstown Road facilities are involved.

Because the safety and efficacy of the listed drugs has not been established, the FDA is strongly advising consumers who filled prescriptions for these drugs at these two pharmacies to contact their prescribing physician immediately for new prescriptions. Additionally, consumers in possession of the above listed prescription drugs from these pharmacies should call FDA at 800-521-5783 for further information on how to dispose of the drugs.

As an international conference in the fields of health technology and life science, HealthTech & New Drugs China has become China’s most influential professional exposition and platform to bridge the communication among the government, industry, academia, research, fund and service. HealthTech, held once a year, is not only the best platform for leading enterprises and innovative organizations in the healthcare and biotechnology industry to display their latest technologies, products and solutions, but also the best place for industrial leaders, scientists and technical elites to communicate and cooperate with each other.

HealthTech 2008, an international conference of medical and health technology, sponsored by Ministry of Science and Technology and other related authorities, aims to provide the opportunities of academic communications and technology trading with the largest covering conference, highest expertise and the innovation drugs in China. More than 200 high-level sessions would be held and the heavyweights from the government, academia, and industry will be invited to present in the HealthTech Forum.

Comprehensively Matchmaking Symposium

International matchmaking symposium for innovative health technologies and new drugs

According to IPR, national policies and market situation, provide a comprehensive industry platform chain for one-to-one communications on the latest products and technology, outsourcing service, investment & incubation, and HR, and build up the alliance of “government, industry, academia, institutes and capital”.

China began to strengthen its environmental-protection legislation in the 1970s, with provisions to supplement those concerning protection of the environment and natural resources in the Constitution.

Such a system consists roughly of seven parts, that is, the Constitution of the People’s Republic of China, laws on environmental protection, administrative statutes concerning environmental protection, local laws and regulations, rules enforced by environmental protection administrations and local governments, international conventions on protection of the environment, and environmental standards.

The Constitution serves as the base and the core of the country’s environmental legal system. The Environmental Protection Law (revised in 1989) is the fundamental law on environmental protection. All environmental protection laws are adopted and promulgated by the NPC and its Standing Committee, while administrative statutes are formulated and promulgated by the State Council. The related ministries and commissions under the State Council issue environmental protection regulations and rules within the scope of their power. What’s more, the State and localities have also formulated a group of environmental standards.

China has signed and joined some international environmental protection conventions and agreements which include the Vienna Convention on the Protection of the Ozone Layer, Basel Convention on the Control of Trans-boundary Movements of Hazardous Wastes and Their Disposal, UNEP London Guidelines for the Exchange of Information on Chemicals in International Trade, and Rotterdam Convention on the Prior Informed Consent for Certain Hazardous Chemicals and Pesticides in International Trade. They form an integral part of China’s environmental protection legal system.

 

What are the main features of the proposed Regulation on classification, labelling and packaging?

The aim of the proposed Regulation is to enable a judgement on a substance or mixture (preparation) with respect to its hazardous properties and to provide a hazardous chemical with pertinent hazard labelling and information on safety measures. The proposed act

• Applies the general principles of the UN GHS,
• Uses the “building block approach” of the UN GHS and a few other options to adapt the system to the EU’s needs,
• Keeps the scope as close as possible to the existing EU system,
• Maintains the current level of protection by including EU “left-overs” that are not yet covered by the GHS, e.g. ozone depletion, EUH014, EUH066,
• Ensures consistency with transport,
• Takes over the current Annex I of Council Directive 67/548/EEC,
• Takes over Title XI (Classification & Labelling Inventory) from the REACH Regulation,
• Defines a transitional period during which both the current legislation and the new Regulation will be in place,
• Stays as close as possible to the UN GHS format and terminology, e.g. “mixture” instead of “preparation”, or “hazardous” instead of “dangerous”,
• But maintains the concept of “dangerous”, to avoid changing the scope of REACH and other Community legislation,

As with the current legislation, the proposed Regulation is intended to be primarily a self-classification system for enterprises. It stipulates that after entry into force the deadline for substance reclassification is 30 November 2010 and for mixtures 31 May 2015. The current Directives on classification, labelling and packaging, i.e. Council Directive 67/48/EEC and Directive 1999/45/EC, will be repealed on 1 June 2015.

What is the history of the Commission proposal?

The Globally Harmonised System of Classification and Labelling of Chemicals (GHS) provides a harmonised basis for globally uniform physical, environmental and health and safety information on hazardous chemical substances and mixtures. In its Plan of Implementation, adopted in Johannesburg on 4 September 2002, the World Summit on Sustainable Development encouraged countries to implement the harmonised system as soon as possible, with a view to reach a full operational state by 2008. The European Commission and the EU Member States endorsed the UN recommendation to implement the GHS in domestic law. The recommendation was also supported by stakeholders from industry and non-governmental organisations.

On 27 June 2007, the European Commission adopted a proposal (COM(2007) 355 final) for a Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006. This proposal takes account of the comments received during public stakeholder consultation in autumn 2006. Together with the proposal, the Commission presented an impact assessment to the European Parliament and to the Council.

Stakeholder Consultation

The Commission launched a public stakeholder consultation on the internet from 21 August to 21 October 2006. All stakeholder replies were published on the internet. Some 370 contributions were received. 82% were sent by industry - associations or companies ; of the 254 company responses, 45% came from enterprises with less than 250 employees. 10 NGOs and one trade union responded.

18 Member State governments and/or public authorities sent comments. Non-EU public authorities (Iceland, Norway, Switzerland; Romania was not yet a Member State at that time) gave input as well. No international organisation sent comments. 97% of the responses supported the implementation of the GHS in the EU and 96% of these by means of a Regulation.

Based on the replies and comments, the Commission Services drafted an evaluation of the stakeholder replies . The points raised by the various stakeholders were considered and widely taken up in the revised proposal.

Downstream legislation

Classification of substances and preparations (GHS: “mixtures”) triggers other obligations in EU legislation, referred to as downstream legislation.

The Commission services have assessed the potential effects of the implementation of the GHS criteria on downstream legislation.

Analysis of the Potential Effects of the Proposed GHS Regulation on Its EU Downstream Legislation (DG Enterprise) and Addendum .

The analysis concludes that effects are either minimal or can be minimised by appropriate changes to particular downstream acts. This draft Regulation includes such changes to REACH. For Council Directive 1996/82/EC on the control of major-accident hazards involving dangerous substances (Seveso II Directive), the implementation of GHS is expected to have a more substantial impact. Therefore, this Directive needs to be amended separately. Separate amendments implementing the GHS in other EU downstream acts will be part of further Commission proposals. On 16 and 17 October 2007, the Commission adopted two proposals (COM(2007)611 final and COM(2007)613 final) implementing the GHS for seven pieces of EU downstream legislation.

What is REACH ?

REACH is a new European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. The new law entered into force on 1 June 2007.

The aim of REACH is to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. At the same time, innovative capability and competitiveness of the EU chemicals industry should be enhanced. The benefits of the REACH system will come gradually, as more and more substances are phased into REACH.

The REACH Regulation gives greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. Manufacturers and importers will be required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database run by the European Chemicals Agency (ECHA) in Helsinki. The Agency will act as the central point in the REACH system: it will manage the databases necessary to operate the system, co-ordinate the in-depth evaluation of suspicious chemicals and run a public database in which consumers and professionals can find hazard information.

The Regulation also calls for the progressive substitution of the most dangerous chemicals when suitable alternatives have been identified. For more information read: REACH in Brief.

REACH has been developed in a climate of transparency and consultation. The Commission has held extensive dialogue with stakeholders before and after the proposal was presented. Stakeholders sent over 6000 responses during the REACH internet consultation and contributed to the REACH Impact Assessment both before and after the launch of the Commission REACH proposal in 2003. This helped the Commission to improve the design and cost-effectiveness of the system and subsequently the European Parliament and the Council of the European Union to amend the proposal under the co-decision procedure.

REACH provisions will be phased-in over 11 years. Companies can find explanations of REACH in the guidance documents and can address themselves to a number of helpdesks.

The Commission will carry out a number of reviews of REACH Annexes within 18 months after entry into force

How will REACH work?

All manufacturers and importers of chemicals must identify and manage risks linked to the substances they manufacture and market. For substances produced or imported in quantities of 1 tonne or more per year per company, manufacturers and importers need to demonstrate that they have appropriately done so by means of a registration dossier, which must be submitted to the European Chemicals Agency (ECHA).

The Agency may then check that the registration dossier complies with the Regulation and must evaluate testing proposals to ensure that the assessment of the chemical substances will not result in unnecessary testing, especially on animals.

Where appropriate, authorities may also select substances for a broader substance evaluation to further investigate substances of concern.

REACH also foresees an authorisation system aiming to ensure that substances of very high concern are properly controlled, and progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. Where this is not possible, the use of substances may only be authorised where there is an overall benefit for society of using the substance.

In addition, EU authorities may impose restrictions on the manufacture, use or placing on the market of substances causing an unacceptable risk to human health or the environment.

The Member States authorities are responsible for enforcing REACH through inspections as well as penalties in case of non-compliance.

PIT 

Pioneers International Trading Co., Ltd. stepping into Pioneers’ world

as china is the largest and most attractive  developing market for pharmaceuticals in the world, so Pioneers has to lead the field of  new pharmamchinery and generics update continously by different communication ways (magazines, fairs, visiting, meeting,…) 

not only inland but also all over the world specially the area of Middle-east and Africa, so we have to take the customer to meet the change of the world as we bring the change

 1- It must be our doing towards work future plan.

2- we started from their end then developed to show the change.

3- work effeciency according to company earn or income.

4-  informed that the gradual change in balance of sales contributed by domestic and foreign companies in the chinese pharma market 2007-2020 so that it is a growth bloom for chinese pharma.

5- doing on the customer service and patiently for their situation and discusion too.

6- following the customers any where any time for any request available.

7-pushing the customer for finializing the order when its became slowly as “fishing theory”.

8-let us start, work, join, and doing together as a teamwork for ever.

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