NEW E-FILING PRICING SYSTEM FOR INDIA
India’s National Pharmaceuticals Pricing Authority (NPPA) has recently introduced an online e-filing system for applicants wishing to apply for pricing or revised pricing of their medical product. The price list is listed under Forms III, IV, and V of the Drug Price Control Order (DPCO) 1995.

This e-filing system is voluntary, and is designed for more efficient, expedited review of drug prices. The manual filing under DPCO 1995 will still be available. The e-filing system is accessible at http://nppaefile.nic.in/.

The NPPA has posted instructions for filling out these online forms. Forms will be editable as many times as needed until final submission is complete. Also, when an applicant begins to fill in these online forms, he or she will receive a unique form number which can be used to see, modify, and print the application before final submission. Printouts can also be done as many times as needed until the final submission.

Once an applicant finalizes the form by clicking “Final Submission,” no additional corrections can be made. Applicants are then required to make a printout of this Final Submission, which will bear the unique form number. The applicant must then submit this printout to the NPPA by post along with the required supporting documents.

If the hard copy with the unique form number does not reach the NPPA within one month of making the final e-filing submission, the e-filed data will be automatically deleted from the database. Therefore, a new application will have to be filled out.

PHILIPPINES TRANSFERS MEDICAL DEVICE RESPONSIBILITIES
The Philippines’ Department of Health (DOH) has recently issued Administrative Order No. 2007-003 which transfers some medical device regulation responsibilities from the Bureau of Food and Drugs (BFAD) to the Bureau of Health Devices and Technology (BHDT). Joint Bureau Memorandum No. 2007-1 was issued on April 23, 2007, clarifying in more detail what this transfer will entail.

The Bureau of Health Devices and Technology (BHDT) was created in 1999. However, the DOH’s concerns of efficiency and capacity have led to new administrative changes to the BHDT.

The BFAD will transfer the following responsibilities to the BHDT:
1) Product registration of medical device products listed in BFAD Memorandum Circular No. 7.s. 1992 (http://www.bfad.gov.ph/MC/mc%207%201992.pdf).
a. Products include endotracheal tubes, nebulizers, catheters, HIV testing kits, hepatitis testing kits, etc.
2) Licensing of a medical device establishment as a distributor.

In the interim, the BFAD will provide on-the-job training to the BHDT. Also, the License to Operate (LTO) a medical device establishment as a manufacturer, trader, repacker, or importer of raw materials will continue to be BFAD’s responsibility until BHDT has the appropriate resources. In addition to training sessions, BHDT will also be involved in inspection of medical device manufacturing plants.

All applications for Certificate of Product Registration (CPR) and License to Operate (LTO) medical device establishments filed before April 30, 2007 will still be processed by the BFAD.

After this date, all applications for CPR and LTO as a distributor should be submitted to the BHDT. However, automatic and regular renewals for CPRs should still be filed to the BFAD.

The BHDT will assign a control number for every application for CPR or LTO. The BHDT will evaluate applications according to the existing guidelines and standards established by the BFAD. Fees will also be based on the schedule set up by the BFAD. The BHDT will prepare the CPR and LTO using the existing format set by the BFAD.

In short, these new responsibilities will simply transfer from the BFAD to the BHDT with no major changes to the current application and review system.

JAPAN'S CHANGING BIOTECHNOLOGY MARKET
The biotech market in Japan is one of the largest in the world at over $15 billion. With various government incentives such as tax exemptions and annual funding, the biotech market is steadily growing. Foreign companies have also increased their presence with subsidiaries in Japan, especially with more lenient financial requirements to establish branch offices.

The Pharmaceuticals and Medical Devices Agency (PMDA) has recently proposed a biosimilar approval pathway to expedite drug registration and approval processes. At the PMDA 1st International Symposium on Biologics, a framework was presented where the PMDA will look for comparability with an approved, precursor product. There are various pathways to reach the comparability, from citing nonclinical and clinical studies to referencing a manufacturer’s accumulated experience and data.

The main factors the PMDA focused on for comparability were the presence of highly similar quality attributes before and after manufacturing processes between the two products and no adverse impact on the safety and efficacy of the new product.

The PMDA hopes that with comparability studies, the need to test data during product registration would be reduced. With decreased testing requirements, the PMDA also hopes that drug development will become more effective and economical. However, the PMDA admitted that comparability studies may not be sufficient in ensuring the quality, safety, and efficacy of the subsequent product. Also, the PMDA has suggested that this comparability may only be available for nonconjugated protein products and not for conjugate proteins. Examples of nonconjugated protein products include insulin, somatotropin (hGH), and filgrastim.

Japan is taking strides to address its growing biotechnology market. However, the Symposium also covered many other issues which Japan will have to address in the future. For example, the PMDA suggested close post-marketing surveillance and monitoring to ensure the quality, safety, and efficacy of the newly-approved subsequent product. In addition, the PMDA proposed comparability studies for each intended indication, while different dosage forms or new indications different from the original product would require extensive data.

MALAYSIA FREE TRADE AGREEMENT DISCUSSIONS WITH US
Despite numerous rounds, the US and Malaysia continue to have ongoing negotiations over the regulations of drugs and patents under a future Free Trade Agreement. The deadline for fast-track approval has passed, and resolutions to patents and generics regulations are not forthcoming.

For generics, the main issue is data exclusivity. Currently, under the WTO’s regulations, drug manufacturers are allowed 20 years’ patent protection on their drug products. However, there have been proposals to include data exclusivity under the US and Malaysia’s future Free Trade Agreement. This data exclusivity would require generic companies to conduct their own clinical trials, which are time consuming and often too costly for generic companies. In addition, governments would not be able to cite clinical test data when considering marketing approval for a generic product.

In Malaysia, marketing approval only requires proof of bioequivalence between the generic and original product. Since the government has access to proprietary clinical test data, it can easily determine this bioequivalence without requiring the generic company to conduct its own clinical trials.

There has also been discussion on extending patents to account for unanticipated delays in marketing approval period or during the patent review process.