MHLW ESTABLISHES NEW SYSTEM FOR CONSULTATION IN JAPAN
In the past, visits to Japan’s Ministry of Health, Labor and Welfare (MHLW) for advice were free and non-binding. At these sessions, the MHLW officials usually would not make any comments, or if any comments were made, they normally did not carry weight in future discussions. Now, the MHLW will be offering a new consultation service for medical companies in Japan. While the final details are still evolving, the service includes three types of consultation.

First, a Preliminary Consultation offers the applicant initial feedback on their situation. The thirty minute service is free of charge and requires only the applicant be present. Generally, two days per month are available for making an appointment and the consultation will take place about one week later. The submittal of materials, including an appointment application form and list of questions, is required at the time of scheduling.

Second, the applicant may schedule a Regular Consultation, providing assistance with the application without prior review of the relevant documents. Appointments are held on Thursdays and Fridays and started on May 20. The scheduling must be done on Thursday, a week prior to the appointment. A list of questions and the relevant materials must be submitted at the time of scheduling. This consultation service lasts thirty minutes and costs 36,200 yen (about $350 USD).

Third, a consultation regarding the application, including prior review of the relevant documents, is provided during a Detailed Consultation. This service will last a maximum of two hours and costs 1,697,200 yen (about $16,000 USD). Along with the applicant, representatives from the manufacturer, as well as experts, are permitted to be present. Following the consultation, the MHLW will prepare the minutes and then issue them after receiving approval from the applicant. A list of questions is required and must be submitted on the Monday three weeks prior to the consultation date. However, the dates for scheduling and holding a Detailed Consultation are being determined now and are not yet available. At the meeting, the MHLW will give a recommendation on what they expect to happen during the regulatory process. While this recommendation will help provide incite into what the MHLW is likely to do, it is still non-binding.

TAIWAN: PHARMACIES RECEIVE ASSISTANCE TO MEET LABELING REQUIREMENTS
After conducting several recent investigations into medicine labeling habits of pharmacies in Taiwan, the Taiwan Department of Health (DOH) found that some pharmacies are failing to comply with the labeling requirements. Currently, several associations in Taiwan are establishing programs to provide additional services to pharmacies, helping to improve labeling procedures and standards.

According to a regulation passed by the DOH in May 2002, medicine labels should contain 13 mandatory items, including the pharmacy name and address, pharmaceutical name, the dosage and administration, etc. The DOH suggests that three additional items be included on the label: main medical indicators, main side-effects, and any other items (warnings, special storage methods, etc.). The DOH investigation found that some pharmacies do not comply with the mandatory regulations, and very few pharmacies include the optional warning information. The Bureau of Pharmaceutical Affiars (BoPA) will take action against improper labeling, fining pharmacists up to NT$6000 (approximately $180) if they do not abide by the DOH labeling regulations.

In order to improve labeling in pharmacies, two groups are taking measures to provide for easier labeling methods. First, the Medical Affairs Bureau will issue a CD-ROM to pharmacies, providing the required labeling information for over 200 prescription drugs. A pharmacy will be able to print out information about a particular drug and include it with the medication. Second, the Taiwanese National Union of Pharmacist Associations is currently compiling a list of frequently used medical warnings. In the future, the Union will provide pharmacies with a list of these warnings in the form of labels.

PHARMACEUTICAL REGISTRATION IN HONG KONG: AN UPDATE
When applying for a Certificate for Clinical Trial/Medicinal Test in Hong Kong, a summary of the pre-clinical studies (or alternate similar information) is now required as part of the application packet. The registration and payment may be submitted Monday through Friday, between the hours of 9:00am and 1:00pm or 2:00pm and 5:00pm. The office is also open on Saturday between 9:00am and 1:00pm. To receive an application, a written request must be submitted to the following updated address: Pharmaceutical Registration and Import/Export Control Section, Pharmaceutical Service, Department of Health, 3/F Public Health Laboratory Center, 382 Nam Cheong Street, Shek Kip Mei, Kowloon.

In addition, as of February 2004, the labels of all medicines dispensed by a pharmacy or medical practitioner should include the following information: (a) name of the patient, (b) date of dispensing, (c) name and address of the pharmacy or medical practitioner, (d) trade name or common name of the medicine, (e) dosage per unit, (f) method and dosage of administration, and (g) a precaution where applicable.

NEW IT SERVICES IN KOREAN HOSPITALS
The implementation of new information technology (IT) services in Korean hospitals enables patients to receive faster and more accurate diagnosis and treatment. These new IT services include the use of the Internet for remote diagnosis, teleconferencing, and the establishment of internal computer networks in some hospitals. Although these services are only in their beginning stages and some legal issues, such as the confidentiality of a patient’s medical records, have yet to be resolved, Koreans are able to benefit from these new and more technologically-advanced services and receive better and faster medical care at hospitals.

Some Korean hospitals are integrating teleconferencing systems, thereby allowing patients to have access to doctors and specialists, regardless of the patient’s location or situation. In the past, many patients were forced to travel several hours to reach the nearest hospital. Now, as rural areas become connected to urban medical centers via teleconferencing technology, patients can receive a medical diagnosis and treatment without leaving their rural towns. In addition, many small hospitals would normally send negatives or other images to larger hospitals to be processed and diagnosed, oftentimes forcing patients to wait several days for the results. But now that some hospitals have access to the Internet, digital files of negatives can be sent to a hospital, processed, and returned with the results in a matter of hours.

The Electric Medical Record System is also contributing to the increased efficiency of hospitals. This system stores a patient’s medical information, health records and previous treatment information in the hospital’s database. Therefore, hospital staff can access a patient’s medical records very quickly by using a computer, rather than searching through thousands of paper charts. This method of storing and locating medical records also allows the hospital staff to spend more time with the patient, and less time doing administrative work.

Despite the new IT services offered by Korean hospitals, standardizations and legal revisions still need to be made. For instance, the databases that many hospitals are creating to store patient’s records are not standardized among hospitals, and use different digital formats, making it very difficult to transfer a patient’s record between hospitals. Hospitals also tend to use different photo archiving data systems, making it difficult for other hospitals to read x-rays and other image files. There are also concerns about the confidentiality of a patient’s medical records after the records are transferred into digital format. Currently, a law such as the U.S. HIPAA is not present in Korea.